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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Antiserum, Control, Antithrombin Iii
510(k) Number K932713
Device Name TRACE TRANSFERRIN REAGENT
Applicant
Trace Scientific , Ltd.
10 Treforest Dr.
Clayton, Vic 3168,  AU
Applicant Contact David Johnston
Correspondent
Trace Scientific , Ltd.
10 Treforest Dr.
Clayton, Vic 3168,  AU
Correspondent Contact David Johnston
Regulation Number864.7060
Classification Product Code
DDQ  
Date Received06/04/1993
Decision Date 09/30/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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