Cleared Traditional

COULTER AST (GOT) REAGENT

K897165 · Coulter Electronics, Inc. · Chemistry
Feb 1990
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K897165 is an FDA 510(k) clearance for the COULTER AST (GOT) REAGENT, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on February 23, 1990, 57 days after receiving the submission on December 28, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K897165 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 1989
Decision Date February 23, 1990
Days to Decision 57 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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