510(k) · Cleared

Cleared

Kodak Ekta-Chem Clinical Chem. Slides

K802376510(k) TraditionalCleared Oct 23, 198023-day reviewClass II21 CFR 862.1160

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

Eastman Kodak Company · CHS Coulometric Method, Carbon-Dioxide

Cleared on Oct 23, 1980 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Oct 23, 1980
Review: 23 days
Class: Class II
Product code: CHS
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK802376 Kodak Ekta-Chem Clinical Chem. SlidesEastman Kodak Company · 1980
Descendant · cites it directly · 0 of its ownK093611 Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products…Ortho-Clinical Diagnostics, Inc. · 2010

Most influential descendants

Showing 1 of 1 · See all

K093611Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K802376	Kodak Ekta-Chem Clinical Chem. Slides	Eastman Kodak Company	1980	—
+1	K093611	Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT…	Ortho-Clinical Diagnostics, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K802376, 1980–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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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? (1)

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

Number	Device	Applicant	Decided	Descendants
K093611	Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…	Ortho-Clinical Diagnostics, Inc.	2010	0

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, K093611 (Ortho-Clinical Diagnostics, Inc., 2010) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CHS devices

CHS Coulometric Method, Carbon-Dioxide: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CHS

FDA has decided no CHS device since 2007.

Median 510(k) review, days · CHS

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

Recalls per year · CHS

No recall names CHS since 2007.

Adverse event reports per year · CHS

No MAUDE report names CHS since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K802376 · printed Nov 4, 2026

Cite this page

510(k) Report. “K802376: Kodak Ekta-Chem Clinical Chem. Slides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K802376

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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