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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 kit, cell screening, fetal
510(k) Number BK050005
Tradename Quant-Rho FITC Anti-D for Fetal Cell Assay
Device Name KIT, CELL SCREENING, FETAL
Classification Product Code
MTI  
Date Received02/02/2005
Decision Date 09/27/2005
Decision substantially equivalent (SE)
Review Advisory Committee Pathology
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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