Cleared Traditional

ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT)

K871780 · Biochemical Trade, Inc. · Chemistry
Jun 1987
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K871780 is an FDA 510(k) clearance for the ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT), a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on June 4, 1987, 29 days after receiving the submission on May 6, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K871780 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1987
Decision Date June 04, 1987
Days to Decision 29 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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