Cleared Traditional

CORNING ELISA PLATES

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

About This 510(k) Submission

K863789 is an FDA 510(k) clearance for the CORNING ELISA PLATES, a Device, General Purpose, Microbiology, Diagnostic (Class I — General Controls, product code LIB), submitted by Corning Medical & Scientific (Oneonta, US). The FDA issued a Cleared decision on October 3, 1986, 7 days after receiving the submission on September 26, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K863789 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 1986
Decision Date October 03, 1986
Days to Decision 7 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code LIB — Device, General Purpose, Microbiology, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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