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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 K873135
Device Name UNIFAST GAMMA-GT
Applicant
Sclavo, Inc.
5 Mansard Ct.
Wayne,  NJ  07470
Applicant Contact DEBRA HOFMEISTER
Correspondent
Sclavo, Inc.
5 Mansard Ct.
Wayne,  NJ  07470
Correspondent Contact DEBRA HOFMEISTER
Regulation Number862.1360
Classification Product Code
JQB  
Date Received08/10/1987
Decision Date 09/04/1987
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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