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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igm, Antigen, Antiserum, Control
510(k) Number K842327
Device Name AMER. HISTO-ID SYS PRIMARY IGM S7920-31
Applicant
Bartels Immunodiagnostic Supplies, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Bartels Immunodiagnostic Supplies, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5550
Classification Product Code
DFT  
Date Received06/13/1984
Decision Date 08/02/1984
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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