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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, cmv
510(k) Number BK200476
Tradenames PK CMV-PA System, PK CMV-PA System Control Set
Device Name Test, Donor, CMV
Original Applicant
Fujirebio Diagnostics, Inc
201 great valley parkway
malvern,  PA  19355
Classification Product Code
MZE  
Date Received04/01/2020
Decision Date 10/19/2020
Decision substantially equivalent (SE)
Review Advisory Committee Immunology
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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