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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceFLUORO-CEP (R) PROGESTERONE
Classification Namekit, assay, progesterone receptor
Generic Namekit, assay, progesterone receptor
Regulation Number864.1860
Applicant
ZEUS SCIENTIFIC, INC.
200 evans way
branchburg, NJ 08876
PMA NumberP900025
Date Received04/11/1990
Decision Date09/26/1990
Withdrawal Date 03/26/2009
Product Code
LPI
Docket Number 90M-0442
Notice Date 11/23/1990
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 
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