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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.
 
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
Supplement NumberS001
Date Received12/11/1991
Decision Date04/21/1992
Product Code
LPI
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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