Cleared Traditional

ASPARTATE AMINOTRANSFERASE (AST) TEST

K935181 · Em Diagnostic Systems, Inc. · Chemistry
Jan 1994
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K935181 is an FDA 510(k) clearance for the ASPARTATE AMINOTRANSFERASE (AST) TEST, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on January 27, 1994, 93 days after receiving the submission on October 26, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K935181 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 1993
Decision Date January 27, 1994
Days to Decision 93 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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