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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, identification, hepatitis b antigen
510(k) Number BK840028
Tradename Run Control for HBsAg Assay
Device Name System, Identification, Hepatitis B Antigen
Original Applicant
Biotech Research Laboratories, Inc.
1600 east gude drive
rockville,  MD  20850
Classification Product Code
KSJ  
Date Received12/03/1984
Decision Date 01/25/1985
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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