Cleared Traditional

ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30

K974003 · Diagnostic Chemicals , Ltd. · Chemistry
Dec 1997
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K974003 is an FDA 510(k) clearance for the ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30, a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I — General Controls, product code CKA), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E.I., CA). The FDA issued a Cleared decision on December 5, 1997, 45 days after receiving the submission on October 21, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K974003 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1997
Decision Date December 05, 1997
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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