Cleared Traditional

ALT/GPT REAGENT SET

K844251 · Sterling Biochemical, Inc. · Chemistry
Jan 1985
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K844251 is an FDA 510(k) clearance for the ALT/GPT REAGENT SET, a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I — General Controls, product code CKA), submitted by Sterling Biochemical, Inc. (Dearborn, US). The FDA issued a Cleared decision on January 8, 1985, 67 days after receiving the submission on November 2, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K844251 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1984
Decision Date January 08, 1985
Days to Decision 67 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CKA — Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1030

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