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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 centrifuges (micro, ultra, refrigerated) for clinical use
510(k) Number BK080057
Tradename My Cells Autologous Platelet Preparation Kit
Device Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Original Applicant
Kaylight Corporation
602 anacapa
irvine,  CA  92602
Regulation Number862.2050
Classification Product Code
JQC  
Date Received09/03/2008
Decision Date 09/25/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
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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