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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 K935177
Device Name GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
Applicant
Em Diagnostic Systems, Inc.
Div. Of Em Industries Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact CAROL FAULKNER
Correspondent
Em Diagnostic Systems, Inc.
Div. Of Em Industries Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact CAROL FAULKNER
Regulation Number862.1360
Classification Product Code
JQB  
Date Received10/26/1993
Decision Date 12/16/1993
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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