Cleared Traditional

AST OR SGOT

K971344 · Carolina Liquid Chemistries Corp. · Chemistry
Apr 1997
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K971344 is an FDA 510(k) clearance for the AST OR SGOT, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on April 21, 1997, 11 days after receiving the submission on April 10, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K971344 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 1997
Decision Date April 21, 1997
Days to Decision 11 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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