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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 NameABBOTT ER-EIA MONOCLONAL DIAG. KIT
Classification Namekit, assay, estrogen receptor
Generic Nameestrogen receptor assay kit
Regulation Number864.1860
ApplicantABBOTT LABORATORIES
PMA NumberP850029
Date Received05/17/1985
Decision Date10/17/1988
Withdrawal Date 10/15/2003
Product Code
LPJ
Docket Number 88M-0368
Notice Date 12/16/1988
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 
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