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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 K881311
Device Name BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
Applicant
Biotrol, USA, Inc.
5 Great Valley Pkwy., Suite 248
Great Valley Corp. Center
Malvern,  PA  19355
Applicant Contact ALLAN C MURPHY
Correspondent
Biotrol, USA, Inc.
5 Great Valley Pkwy., Suite 248
Great Valley Corp. Center
Malvern,  PA  19355
Correspondent Contact ALLAN C MURPHY
Regulation Number862.1360
Classification Product Code
JQB  
Date Received03/28/1988
Decision Date 04/28/1988
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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