Cleared Traditional

K875071 - ASPARTATE AMINOTRANSFERASE AST/SGOT
(FDA 510(k) Clearance)

K875071 · Tech-Co, Inc. · Chemistry
Feb 1988
Decision
71d
Days
Class 2
Risk

K875071 is an FDA 510(k) clearance for the ASPARTATE AMINOTRANSFERASE AST/SGOT, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on February 18, 1988, 71 days after receiving the submission on December 9, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K875071 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 1987
Decision Date February 18, 1988
Days to Decision 71 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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