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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, qualitative, for hla, non-diagnostic
510(k) Number BK820016
Tradenames ARC HLA Extended Trays, ARC HLA Trays
Device Name Test, Qualitative, for HLA, Non-Diagnostic
Original Applicant
American Red Cross Blood Services
15601 crabbs branch way
rockville,  MD  20855
Classification Product Code
MZI  
Date Received03/04/1983
Decision Date 06/01/1983
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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