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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 K791493
Device Name ANTI-NUCLEAR ANTIBODY TEST
Applicant
Meloy Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Meloy Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5100
Classification Product Code
DHN  
Date Received08/02/1979
Decision Date 09/24/1979
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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