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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 BK960001
Tradename OPUS CMV
Device Name Test, Donor, CMV
Original Applicant
Behring Diagnostics
175 university avenue
westwood,  MA  02090
Classification Product Code
MZE  
Date Received01/02/1996
Decision Date 10/09/1996
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 Yes
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