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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 CIRCLE
SUITE 200
WAUKESHA,  WI  53186 -4054
Applicant Contact LEIGH ANN TIDEY
Correspondent
GENETIC TESTING INSTITUTE
20925 CROSSROADS CIRCLE
SUITE 200
WAUKESHA,  WI  53186 -4054
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
Recalls CDRH Recalls
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