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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 K760346
Device Name ASSAY FOR GAMMA GLUTAMYLTRANSFERASE
Applicant
PRINCETON BIOMEDIX
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PRINCETON BIOMEDIX
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1360
Classification Product Code
JPZ  
Date Received08/02/1976
Decision Date 10/27/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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