Cleared Traditional

NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522

K901702 · American Research Products Co. · Chemistry
Apr 1990
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K901702 is an FDA 510(k) clearance for the NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522, a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I — General Controls, product code CKA), submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on April 25, 1990, 13 days after receiving the submission on April 12, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K901702 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1990
Decision Date April 25, 1990
Days to Decision 13 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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