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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 K810863
Device Name KALLESTAD HEP-2 CELL LINE SUBSTRATE
Applicant
Kallestad Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Kallestad Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5090
Classification Product Code
DBM  
Date Received03/31/1981
Decision Date 04/14/1981
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
Recalls CDRH Recalls
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