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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 BK920025
Tradename Dade Fetal-Cyte Screening Kit
Device Name KIT, CELL SCREENING, FETAL
Original Applicant
Baxter Healthcare Corporation
1 baxter pkwy.
deerfield,  IL  60015
Classification Product Code
MTI  
Date Received08/28/1992
Decision Date 08/05/1993
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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