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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Groups, Salmonella Spp.
510(k) Number K912791
Device Name SALMONELLA O GROUPING ANTISERA SET
Applicant
S.M.I. Medical, Inc.
491 W. Main St.
Avon,  MA  02322
Applicant Contact RONALD A.SELBY
Correspondent
S.M.I. Medical, Inc.
491 W. Main St.
Avon,  MA  02322
Correspondent Contact RONALD A.SELBY
Regulation Number866.3550
Classification Product Code
GRM  
Date Received06/25/1991
Decision Date 10/05/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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