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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.
 
Trade NameFLUORO-CEP{R} ESTROGEN ASSAY REAGENT
Classification Namekit, assay, estrogen receptor
Generic Nameestrogen receptor assay kit
Regulation Number864.1860
ApplicantZEUS TECHNOLOGIES
PMA NumberP860015
Date Received04/28/1986
Decision Date02/29/1988
Withdrawal Date 03/26/2009
Product Code
LPJ
Docket Number 88M-0091
Notice Date 05/11/1988
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 
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