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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 K874933
Device Name MUG-INDOLE DISC
Applicant
Scott Laboratories, Inc.
190 N. Cities Service Hwy.
Sulphur,  LA  70663
Applicant Contact DORIS MCCULLOCH
Correspondent
Scott Laboratories, Inc.
190 N. Cities Service Hwy.
Sulphur,  LA  70663
Correspondent Contact DORIS MCCULLOCH
Regulation Number866.2660
Classification Product Code
JTO  
Date Received12/04/1987
Decision Date 01/05/1988
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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