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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 K071255
Device Name ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A
Applicant
HYPHEN BIOMED
6560 GOVE COURT
MASON,  OH  45040
Applicant Contact OLA ANDERSON
Correspondent
HYPHEN BIOMED
6560 GOVE COURT
MASON,  OH  45040
Correspondent Contact OLA ANDERSON
Regulation Number864.7695
Classification Product Code
LCO  
Date Received05/04/2007
Decision Date 09/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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