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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 BK080051
Tradename FETALSCREEN
Device Name KIT, CELL SCREENING, FETAL
Classification Product Code
MTI  
Date Received09/29/2008
Decision Date 04/08/2009
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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