Kodak Ektachem Clin. Chem. Slides (Amyl)

K812027510(k) TraditionalCleared Aug 3, 198114-day reviewClass II21 CFR 862.1070Recalls 5

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

Eastman Kodak Company · CIW Starch-Dye Bound Polymer, Amylase

Cleared on Aug 3, 1981 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 5 times.

Decided: Aug 3, 1981
Review: 14 days
Class: Class II
Product code: CIW
Recalls: 5
Predicates: 0

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

FIG. 1 — Lineage of K812027Source: FDA 510(k) database · 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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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?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 11, 2020	Class II	Z-2364-2020	Under Investigation by firm	Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
May 11, 2020	Class II	Z-2366-2020	Under Investigation by firm	Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
May 11, 2020	Class II	Z-2367-2020	Under Investigation by firm	Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
May 11, 2020	Class II	Z-2365-2020	Under Investigation by firm	Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
Jun 12, 2013	Class II	Z-0298-2014	Equipment maintenance	Ortho 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.

How does its category compare?

All CIW devices

CIW Starch-Dye Bound Polymer, Amylase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CIW

FDA has decided no CIW device since 2007.

Median 510(k) review, days · CIW

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

Recalls per year · CIW

1in 2013

2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · CIW

No MAUDE report names CIW since 2007.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	1	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

https://510kreport.com/device/K812027 · printed Nov 6, 2026

Cite this page

510(k) Report. “K812027: Kodak Ektachem Clin. Chem. Slides (Amyl).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K812027

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026