Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30— 510(k) K974000

Name: FDA 510(k) clearance K974000
Creator: U.S. Food and Drug Administration
Published: 1997-11-04

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K974000 for Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30, Substantially Equivalent on 1997-11-04. Applicant: Diagnostic Chemicals , Ltd.. Device class: 1.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code JQB
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1997-10-21
Decision date: 1997-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E.I., CA

Download summary PDF View on FDA.gov ↗

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