Cleared Traditional

ALANINE AMINOTRANSFERASE (ALT) TEST

K935180 · Em Diagnostic Systems, Inc. · Chemistry
Jan 1994
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K935180 is an FDA 510(k) clearance for the ALANINE AMINOTRANSFERASE (ALT) TEST, a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I — General Controls, product code CKA), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on January 13, 1994, 79 days after receiving the submission on October 26, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K935180 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 1993
Decision Date January 13, 1994
Days to Decision 79 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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