Cleared Traditional

K863789 - CORNING ELISA PLATES

K863789 is the FDA 510(k) clearance for CORNING ELISA PLATES by Corning Medical & Scientific. It is a Class 1 Chemistry device (product code LIB) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K863789 · Corning Medical & Scientific · Chemistry device
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Oct 1986
Decision
7d
Days
Class 1
Risk

K863789 is an FDA 510(k) clearance for the CORNING ELISA PLATES. Classified as Device, General Purpose, Microbiology, Diagnostic (product code LIB), Class I - General Controls.

Submitted by Corning Medical & Scientific (Oneonta, US). The FDA issued a Cleared decision on October 3, 1986 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2660 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Corning Medical & Scientific devices

Submission Details

510(k) Number K863789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1986
Decision Date October 03, 1986
Days to Decision 7 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 88d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIB Device, General Purpose, Microbiology, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LIB Device, General Purpose, Microbiology, Diagnostic

All 13
Devices cleared under the same product code (LIB) and FDA review panel - the closest regulatory comparables to K863789.
SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB
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K912558 · Gull Laboratories, Inc. · Sep 1991
CORNING EASY WASH ELISA PLATES
K872273 · Corning Medical & Scientific · Jul 1987
MICROSCOPE SLIDES
K862112 · Abco Dealers, Inc. · Jun 1986
IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES
K854423 · Dynatech Laboratories, Inc. · Nov 1985
READER MICROELISA SYSTEM
K831641 · Organon Teknika Corp. · Aug 1983