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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 BK940035
Tradename Olympus PK TM CMV System & System Controls
Device Name Test, Donor, CMV
Original Applicant
Hemagen Diagnostics, Inc.
9033 red branch road
columbia,  MD  21045
Classification Product Code
MZE  
Date Received06/23/1994
Decision Date 07/15/1996
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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