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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
510(k) Number K802308
Device Name T/K (ATA/AMA) UNIVERSAL BIOPAK
Applicant
Bioware Products
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Bioware Products
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5090
Classification Product Code
DBM  
Date Received09/23/1980
Decision Date 12/01/1980
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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