Cleared Traditional

AST S.C.E. (GOT)

K863054 · J. D. Assoc. · Chemistry
Jan 1987
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K863054 is an FDA 510(k) clearance for the AST S.C.E. (GOT), a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on January 13, 1987, 154 days after receiving the submission on August 12, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K863054 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1986
Decision Date January 13, 1987
Days to Decision 154 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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