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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 test, donor, syphilis, antigens, treponemal
510(k) Number BK030007
Tradename Olympus PK TP System
Device Name Test, Syphilis, Treponema (FOR DONOR TESTING)
Original Applicant
Fujirebio Diagnostics, Inc.
201 great valley parkway
malvern,  PA  19355
Regulation Number866.3830
Classification Product Code
MYR  
Date Received02/07/2003
Decision Date 02/21/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Immunology
Type 510(k) Special
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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