Corning Elisa Plates

K863789510(k) TraditionalCleared Oct 3, 19867-day reviewClass I21 CFR 866.2660

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

Corning Medical & Scientific · LIB Device, General Purpose, Microbiology, Diagnostic

Cleared on Oct 3, 1986 after a 7-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided: Oct 3, 1986
Review: 7 days
Class: Class I
Product code: LIB
Recalls: None
Predicates: 0

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

FIG. 1 — Lineage of K863789Source: 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.

Planning a device in LIB? 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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All LIB devices

LIB Device, General Purpose, Microbiology, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LIB

FDA has decided no LIB device since 2007.

Median 510(k) review, days · LIB

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

Recalls per year · LIB

1in 2025

2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · LIB

1in 2025

2007high 3 (2016) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	2	0
2015	—	0	0
2016	—	1	3
2017	—	0	1
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	2
2024	—	0	0
2025	—	1	1
2026	—	0	—

https://510kreport.com/device/K863789 · printed Nov 4, 2026

Cite this page

510(k) Report. “K863789: Corning Elisa Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K863789

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Record history

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