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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameIMMUNOCYTOCHEMICAL ASSAY TO DETECT PROGESTERONE
Classification Namekit, assay, progesterone receptor
Regulation Number864.1860
ApplicantABBOTT LABORATORIES
PMA NumberP920006
Date Received02/06/1992
Decision Date09/26/1995
Withdrawal Date 09/12/2007
Product Code
LPI
Docket Number 96M-0219
Notice Date 07/12/1996
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the abbott pgr-ica monoclonal.
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