Cleared Traditional

K851994 - AST ASPARTATE AMINOTRANSFERASE REAGENT
(FDA 510(k) Clearance)

K851994 · Alpkem Corp. · Chemistry
Jun 1985
Decision
27d
Days
Class 2
Risk

K851994 is an FDA 510(k) clearance for the AST ASPARTATE AMINOTRANSFERASE REAGENT, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on June 3, 1985, 27 days after receiving the submission on May 7, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K851994 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1985
Decision Date June 03, 1985
Days to Decision 27 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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