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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.
 
Trade NameFLUORO-CEP{R} ESTROGEN ASSAY REAGENT
Classification Namekit, assay, estrogen receptor
Generic Nameestrogen receptor assay kit
Regulation Number864.1860
ApplicantZEUS TECHNOLOGIES
PMA NumberP860015
Supplement NumberS001
Date Received12/11/1991
Decision Date04/21/1992
Product Code
LPJ
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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