Cleared Traditional

K952744 - ALANINE AMINOTRANSFERASE REAGENT SYSTEM
(FDA 510(k) Clearance)

K952744 · Medical Diagnostic Technologies, Inc. · Chemistry

Aug 1995

Decision

52d

Days

Class 1

Risk

K952744 is an FDA 510(k) clearance for the ALANINE AMINOTRANSFERASE REAGENT SYSTEM, a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I — General Controls, product code CKA), submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on August 7, 1995, 52 days after receiving the submission on June 16, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number	K952744 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 1995
Decision Date	August 07, 1995
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement