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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kinetic Method, Gamma-Glutamyl Transpeptidase
510(k) Number K945800
Device Name Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05
Applicant
Diagnostic Chemicals , Ltd.
16 First St.
West Royalty Industrial Park
Charlottestown,Pei,Canada,  CA C1E 1B0
Applicant Contact KAREN CALLBECK
Correspondent
Diagnostic Chemicals , Ltd.
16 First St.
West Royalty Industrial Park
Charlottestown,Pei,Canada,  CA C1E 1B0
Correspondent Contact KAREN CALLBECK
Regulation Number862.1360
Classification Product Code
JQB  
Date Received11/28/1994
Decision Date 06/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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