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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 K844381
Device Name COLISTIN 10 MCG. DIFFERENTIAL DISK
Applicant
Anaerobe Systems
3074-A Scott Blvd.
Santa Clara,  CA  95050
Applicant Contact MARION E COX
Correspondent
Anaerobe Systems
3074-A Scott Blvd.
Santa Clara,  CA  95050
Correspondent Contact MARION E COX
Regulation Number866.2660
Classification Product Code
JTO  
Date Received11/13/1984
Decision Date 01/04/1985
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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