Cleared Traditional

Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05

K945800 · Diagnostic Chemicals , Ltd. · Chemistry
Jun 1995
Decision
193d
Days
Class 1
Risk

About This 510(k) Submission

K945800 is an FDA 510(k) clearance for the Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05, a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JQB), submitted by Diagnostic Chemicals , Ltd. (Charlottestown,Pei,Canada, CA). The FDA issued a Cleared decision on June 9, 1995, 193 days after receiving the submission on November 28, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K945800 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 1994
Decision Date June 09, 1995
Days to Decision 193 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JQB — Kinetic Method, Gamma-glutamyl Transpeptidase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1360

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