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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name test, platelet antibody
510(k) Number BK850008
Tradename H.P.C.
Device Name Test, Platelet Antibody Test
Original Applicant
Cooper Biomedical
1 technology court
malvern,  PA  29355
Classification Product Code
MYP  
Date Received04/19/1985
Decision Date 01/09/1986
Decision substantially equivalent (SE)
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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