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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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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