Cleared Traditional

CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT

K803216 · Union Carbide Corp. · Chemistry
Jan 1981
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K803216 is an FDA 510(k) clearance for the CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on January 9, 1981, 22 days after receiving the submission on December 18, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K803216 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1980
Decision Date January 09, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CIT — Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1100

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