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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameRIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT
Classification Namekit, assay, progesterone receptor
Generic Nameprogestin receptor assay kit
Regulation Number864.1860
ApplicantDUPONT MEDICAL PRODUCTS
PMA NumberP820052
Supplement NumberS008
Date Received02/15/1991
Decision Date08/06/1991
Product Code
LPI
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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