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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceSTERILE TROBICIN SUSCEPTIBILITY POWDER(STERILE SPE
Generic NameSusceptibility test powders, antimicrobial
Regulation Number866.1640
ApplicantThe Upjohn Co.
7000 Portage Rd.
Kalamazoo, MI 49001
PMA NumberN50407
Date Received06/30/1971
Decision Date06/30/1971
Reclassified Date05/06/2003
Product Code JTT 
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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