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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
510(k) Number K830214
Device Name AFT SYSTEM III
Applicant
Calbiochem-Behring Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Calbiochem-Behring Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5100
Classification Product Code
DHN  
Date Received01/24/1983
Decision Date 03/09/1983
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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