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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameBARTELS CHEMORESPONSE ASSAY
Classification Nametest, anti-tumor cell susceptibility
Generic Namedrug resistance assay
ApplicantBARTELS PROGNOSTICS, INC.
PMA NumberP940036
Date Received11/23/1994
Decision Date08/01/1996
Product Code
MHR
Docket Number 96M-0471
Notice Date 12/17/1996
Advisory Committee Microbiology
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the bartels chemoresponse assay.
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