510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Kodak Ektachem Clinical Chemistry Slides (LI)

K924488510(k) TraditionalCleared Jan 26, 1993145-day reviewClass II21 CFR 862.3560Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Eastman Kodak Company · JIH Flame Photometry, Lithium

Cleared on Jan 26, 1993 after a 145-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it. It has been recalled 2 times.

Decided
Jan 26, 1993
Review
145 days
Class
Class II
Product code
JIH
Recalls
2
Predicates
0

21 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2006: 3 descendants cleared2013: 2 descendants cleared2005: 1 descendant cleared2008: 1 descendant cleared2010: 1 descendant cleared2012: 1 descendant cleared2011: 5 descendants cleared2007: 2 descendants cleared2014: 1 descendant cleared2021: 1 descendant cleared2019: 1 descendant cleared2015: 1 descendant cleared1990200020102020
  1. This deviceK924488 Kodak Ektachem Clinical Chemistry Slides (LI)Eastman Kodak Company · 1993
  2. Descendant · cites it directly · 20 of its ownK963627 (Modified Version) Integra Ion Selective Electrode (Ise) ModuleRoche Diagnostic Systems, Inc. · 1996
  3. Descendant · 2 generations on · 15 of its ownK052007 Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 2005 · Recalled
  4. Descendant · 3 generations on · 3 of its ownK060854 Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · Recalled
  5. Descendant · 3 generations on · 2 of its ownK123171 Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra…Horiba Abx Sas · 2013
  6. Descendant · 2 generations on · 1 of its ownK123726 Cobas 8000 Ise Indirect NA, K, CI for Gen. 2Roche Diagnostics · 2013

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

1996: 12005: 12006: 32007: 22008: 12010: 12011: 52012: 12013: 22014: 12015: 12019: 12021: 1
1996high 5 (2011) · low 0 (1997)2026

Most influential descendants

Showing 5 of 21 · See all
  • K963627(Modified Version) Integra Ion Selective Electrode (Ise) ModuleRoche Diagnostic Systems, Inc. · 1996 · cites it directly20descendants
  • K052007Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 2005 · 2 generations on15descendants
  • K060854Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · 3 generations on3descendants
  • K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas · 2013 · 3 generations on2descendants
  • K123726Cobas 8000 Ise Indirect NA, K, CI for Gen. 2Roche Diagnostics · 2013 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924488Kodak Ektachem Clinical Chemistry Slides (LI)Eastman Kodak Company1993—
+1K963627(Modified Version) Integra Ion Selective Electrode (Ise) ModuleRoche Diagnostic Systems, Inc.1996—
+2K052007Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx20056
+3K060854Abx Pentra 400: LipoproteinsHoriba Abx20062
+3K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical…Horiba Abx Sas2013—
+2K123726Cobas 8000 Ise Indirect NA, K, CI for Gen. 2Roche Diagnostics2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200510
200630
200720
200810
201010
201150
201210
201320
201410
201510
201910
202110
FIG. 1 — Lineage of K924488, 1993–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (21)

See all 21

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K963627(Modified Version) Integra Ion Selective Electrode (Ise) ModuleRoche Diagnostic Systems, Inc.199620

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 1, 2017Class IIZ-1471-2017Nonconforming Material/ComponentIntermittent imprecision in results generated using two specific lots of VITROS Li Slides.
Jun 12, 2013Class IIZ-0316-2014Equipment maintenanceOrtho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K963627 (Roche Diagnostic Systems, Inc., 1996) has gone furthest, with 20 descendants of its own.

How does its category compare?

All JIH devices

JIH Flame Photometry, Lithium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIH

FDA has decided no JIH device since 2007.

Median 510(k) review, days · JIH

Too few JIH 510(k)s in any year since 2007 to give a median.

Recalls per year · JIH

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JIH

5in 2025

2011: 12012: 22013: 22014: 12018: 22021: 12024: 12025: 5
2007high 5 (2025) · low 0 (2007)2025

MAUDE reports naming product code JIH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—01
20120—02
20130—12
20140—01
20150—00
20160—00
20170—00
20180—02
20190—00
20200—00
20210—01
20220—00
20230—00
20240—01
20250—05
20260—0—

More from Eastman Kodak Company

238 FDA decisions under this applicant name. See the company

  • K060550Kodak Directview DR 3000 System 64KW/80KW Generators, Models 6551345, 6551386Eastman Kodak Company · 20063 recalls
  • K060137Kodak Eclipse Image Processing SoftwareEastman Kodak Company · 2006
  • K060079Kodak Model CR-7400 Digital Radiography SystemEastman Kodak Company · 2006
  • K060055Kodak PacsEastman Kodak Company · 2006
  • K053347Kodak Carestream PacsEastman Kodak Company · 2006

Recent decisions in JIH

The JIH category page

  • K050338Modification to: Instaread Lithium SystemAkers Biosciences, Inc. · 2005
  • K031579Instaread Lithium SystemAkers Laboratories, Inc. · 2003
  • K011033Dimension Lithium (LI) Flex Reagent Cartridge, Model DF 132Dade Behring, Inc. · 2001
  • K934106Kodak Ektachem DTSC II Slides (LI)Eastman Kodak Company · 1994
  • K921403Model 654 AnalyzerCiba Corning Diagnostics Corp. · 1992

https://510kreport.com/device/K924488 · printed Nov 4, 2026

Cite this page

510(k) Report. “K924488: Kodak Ektachem Clinical Chemistry Slides (LI).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924488

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026