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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C1q, Antigen, Antiserum, Control
510(k) Number K861499
Device Name BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT
Applicant
Biostar Medical Products, Inc.
Jerry W. Berkstresser
738 Pearl St.
Denver,  CO  80203
Applicant Contact & LAW
Correspondent
Biostar Medical Products, Inc.
Jerry W. Berkstresser
738 Pearl St.
Denver,  CO  80203
Correspondent Contact & LAW
Regulation Number866.5240
Classification Product Code
DAK  
Date Received04/23/1986
Decision Date 06/20/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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