Cleared Traditional

AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

K980030 · Trace America, Inc. · Chemistry
Jan 1998
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K980030 is an FDA 510(k) clearance for the AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST), a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on January 30, 1998, 25 days after receiving the submission on January 5, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K980030 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1998
Decision Date January 30, 1998
Days to Decision 25 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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