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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFLUORO-CEP (R) PROGESTERONE
Generic NameKIT, ASSAY, PROGESTERONE RECEPTOR
Regulation Number864.1860
ApplicantZeus Scientific, Inc.
200 Evans Way
Branchburg, NJ 08876
PMA NumberP900025
Supplement NumberS001
Date Received12/11/1991
Decision Date04/21/1992
Withdrawal Date03/26/2009
Product Code LPI 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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