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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 system, identification, hepatitis b antigen
510(k) Number BK830017
Tradename Hepa-SHure
Device Name System, Identification, Hepatitis B Antigen
Original Applicant
Nuclear-Medical Laboratories, Division
1800 hurd drive
irving,  TX  75061
Classification Product Code
KSJ  
Date Received07/19/1983
Decision Date 10/07/1983
Decision substantially equivalent (SE)
Review Advisory Committee Hematology
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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