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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Latex Agglutination, T. Cruzi
510(k) Number K834328
Device Name DAT TEST FOR CHAGAS' DISEASE
Applicant
Sero-Immuno Diagnostics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Sero-Immuno Diagnostics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3870
Classification Product Code
GNE  
Date Received12/09/1983
Decision Date 03/02/1984
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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