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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 K844382
Device Name VANCOMYCIN 5MCG DIFFERENTIAL DISK
Applicant
Anaerobe Systems
4221 Richmond Rd., NW
Walker,  MI  49534
Applicant Contact MARION E COX
Correspondent
Anaerobe Systems
4221 Richmond Rd., NW
Walker,  MI  49534
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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