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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, hiv detection
510(k) Number BK230833
Tradenames Access HIV Ag/Ab combo, Access HIV Ag/Ab combo Calibrators, Access HIV Ag/Ab combo QC
Device Name Test, HIV Detection
Original Applicant
Beckman Coulter, Inc.
1000 lake hazeltine dr
chaska,  MN  55318
Regulation Number866.3956
Classification Product Code
MZF  
Date Received04/10/2023
Decision Date 07/27/2023
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
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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