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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Platelet Factor 4 Radioimmunoassay
510(k) Number K053559
Device Name PF4 ENHANCED SOLID PHASE ELISA
Applicant
Genetic Testing Institute
20925 Crossroads Cir.
Suite 200
Waukesha,  WI  53186
Applicant Contact LEIGH ANN TIDEY
Correspondent
Genetic Testing Institute
20925 Crossroads Cir.
Suite 200
Waukesha,  WI  53186
Correspondent Contact LEIGH ANN TIDEY
Regulation Number864.7695
Classification Product Code
LCO  
Date Received12/21/2005
Decision Date 01/20/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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