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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 bone marrow collection/transfusion kit
510(k) Number BK970035
Tradename Bioaccess Marrow Collection System
Device Name Bone Marrow Collection/Transfusion Kit
Original Applicant
BioAccess, Inc.
8400 cedar street
silver spring,  MD  20910
Classification Product Code
LWE  
Date Received08/29/1997
Decision Date 12/23/1998
Decision substantially equivalent (SE)
Review Advisory Committee General Hospital
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 No
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