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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K905666
Device Name M. CAT. BUTYRATE DISC
Applicant
Carr-Scarborough Microbiologicals, Inc.
P.O. Box 1328
Stone Mountain,  GA  30086
Applicant Contact LESLIE SCARBOROUGH
Correspondent
Carr-Scarborough Microbiologicals, Inc.
P.O. Box 1328
Stone Mountain,  GA  30086
Correspondent Contact LESLIE SCARBOROUGH
Regulation Number866.2660
Classification Product Code
JTO  
Date Received12/18/1990
Decision Date 02/26/1991
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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