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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameCOBAS BACT
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Nameautomated susceptibility system
Regulation Number866.1645
ApplicantROCHE DIAGNOSTICS GMBH
PMA NumberP840065
Date Received11/30/1984
Decision Date05/30/1986
Reclassified Date 05/06/2003
Product Code
LON[ Registered Establishments with LON ]
Docket Number 86M-0249
Notice Date 07/07/1986
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
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