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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Gamma-Glutamyl Transpeptidase
510(k) Number K850788
Device Name GLUTAMYLTRANSFERASE ASSAY KIT
Applicant
Diagnostic Chemicals, Ltd. (Usa)
West Royalty Industrial Park
Charlottetown, P.E.I.
Canada,  CA CLE IBO
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
West Royalty Industrial Park
Charlottetown, P.E.I.
Canada,  CA CLE IBO
Regulation Number862.1360
Classification Product Code
JPZ  
Date Received02/26/1985
Decision Date 03/19/1985
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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