Cleared Traditional

Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30

K974000 · Diagnostic Chemicals , Ltd. · Chemistry
Nov 1997
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K974000 is an FDA 510(k) clearance for the Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30, a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JQB), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E.I., CA). The FDA issued a Cleared decision on November 4, 1997, 14 days after receiving the submission on October 21, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K974000 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1997
Decision Date November 04, 1997
Days to Decision 14 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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