510(k) Report

510(k) · Cleared

Cleared

Serum/Urine Appli Ilab (TM) Clinical Chemistry System

K943595510(k) TraditionalCleared Nov 28, 1994126-day reviewClass I21 CFR 862.2300

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

Instrumentation Laboratory CO · JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

Cleared on Nov 28, 1994 after a 126-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Nov 28, 1994
Review
126 days
Class
Class I
Product code
JJQ
Recalls
None
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared1998: 1 descendant cleared1990200020102020
  1. This deviceK943595 Serum/Urine Appli Ilab (TM) Clinical Chemistry SystemInstrumentation Laboratory CO · 1994
  2. Descendant · cites it directly · 0 of its ownK980757 Ilab 600 Clinical Chemistry SystemInstrumentation Laboratory CO · 1998
  3. Descendant · cites it directly · 0 of its ownK974125 IL Test AmylaseInstrumentation Laboratory CO · 1997
  4. Descendant · cites it directly · 0 of its ownK974337 IL Test Urea NitrogenInstrumentation Laboratory CO · 1997

Most influential descendants

Showing 3 of 3 · See all
  • K980757Ilab 600 Clinical Chemistry SystemInstrumentation Laboratory CO · 1998 · cites it directly0descendants
  • K974125IL Test AmylaseInstrumentation Laboratory CO · 1997 · cites it directly0descendants
  • K974337IL Test Urea NitrogenInstrumentation Laboratory CO · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943595Serum/Urine Appli Ilab (TM) Clinical Chemistry SystemInstrumentation Laboratory CO1994—
+1K980757Ilab 600 Clinical Chemistry SystemInstrumentation Laboratory CO1998—
+1K974125IL Test AmylaseInstrumentation Laboratory CO1997—
+1K974337IL Test Urea NitrogenInstrumentation Laboratory CO1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199810
FIG. 1 — Lineage of K943595, 1994–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 JJQ? 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
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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? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K980757Ilab 600 Clinical Chemistry SystemInstrumentation Laboratory CO19980
K974125IL Test AmylaseInstrumentation Laboratory CO19970
K974337IL Test Urea NitrogenInstrumentation Laboratory CO19970

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K980757 (Instrumentation Laboratory CO, 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JJQ devices

JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJQ

FDA has decided no JJQ device since 2007.

Median 510(k) review, days · JJQ

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

Recalls per year · JJQ

1in 2025

2008: 22009: 12011: 12022: 12025: 1
2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JJQ

20in 2025

2007: 12008: 42009: 102010: 462011: 62012: 32013: 632014: 692015: 132016: 92017: 102018: 22019: 12021: 32022: 222023: 142024: 72025: 20
2007high 69 (2014) · low 0 (2020)2025

MAUDE reports naming product code JJQ, 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—01
20080—24
20090—110
20100—046
20110—16
20120—03
20130—063
20140—069
20150—013
20160—09
20170—010
20180—02
20190—01
20200—00
20210—03
20220—122
20230—014
20240—07
20250—120
20260—0—

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321 FDA decisions under this applicant name. See the company

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  • K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 20222 recalls

Recent decisions in JJQ

The JJQ category page

  • K013371Ubit-IR300 Infrared Spectrometry SystemOtsuka Pharmaceutical Co., Ltd. · 20011 recall
  • K980120Digene DML 2000 Microplate LuminometerDigene Corp. · 19981 recall
  • K973938Alpha 4 LS Automated Microtiterplate Processor and ReaderSfri, Inc. · 1998
  • K974762Stat TracksAwareness Technology, Inc. · 1998
  • K962113Anthos Phacts Version Microplate ReaderColumbia Bioscience, Inc. · 1996

https://510kreport.com/device/K943595 · printed Nov 4, 2026

Cite this page

510(k) Report. “K943595: Serum/Urine Appli Ilab (TM) Clinical Chemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K943595

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