Cleared Traditional

HICHEM AST REAGENT KIT

K951751 · Hichem Diagnostics · Chemistry
Aug 1995
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K951751 is an FDA 510(k) clearance for the HICHEM AST REAGENT KIT, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on August 2, 1995, 107 days after receiving the submission on April 17, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K951751 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 1995
Decision Date August 02, 1995
Days to Decision 107 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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