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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Cf, All, Mycoplasma Spp.
510(k) Number K832132
Device Name SERA-TEK MYCOPLASMA ANTIBODY TEST
Applicant
Miles Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Miles Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3375
Classification Product Code
GSB  
Date Received07/01/1983
Decision Date 09/20/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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