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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 K880694
Device Name B. CAT CONFIRM
Applicant
Scott Laboratories, Inc.
190 N. Cities Service Hwy.
Sulphur,  CA  70663
Applicant Contact DORIS MUCCULLOCH
Correspondent
Scott Laboratories, Inc.
190 N. Cities Service Hwy.
Sulphur,  CA  70663
Correspondent Contact DORIS MUCCULLOCH
Regulation Number866.2660
Classification Product Code
JTO  
Date Received02/22/1988
Decision Date 06/16/1988
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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