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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 centrifuge, blood-bank for in vitro diagnostic use
510(k) Number BK860037
Tradename Model LR5.22 centrifuge
Device Name Centrifuge, Blood Bank for in vitro Diagnostic Use
Original Applicant
Jouan, Inc.
route 8,box 1202;p.o. box 2716
winchester,  VA  22601
Regulation Number864.9275
Classification Product Code
KSO  
Date Received09/29/1986
Decision Date 12/15/1986
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
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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