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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 K914731
Device Name TRACE GAMMA GT-SS REAGENT
Applicant
Trace Scientific , Ltd.
10 Treforest Dr.
Clayton, Vic 3168,  AU
Applicant Contact PETER MURPHY
Correspondent
Trace Scientific , Ltd.
10 Treforest Dr.
Clayton, Vic 3168,  AU
Correspondent Contact PETER MURPHY
Regulation Number862.1360
Classification Product Code
JQB  
Date Received10/21/1991
Decision Date 11/19/1991
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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