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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 NameRIANEN 3H
Classification Namekit, assay, estrogen receptor
Generic Nameestrogen receptor assay, 3h
Regulation Number864.1860
ApplicantNEW ENGLAND NUCLEAR
PMA NumberP800061
Supplement NumberS004
Date Received10/18/1982
Decision Date12/22/1982
Product Code
LPJ
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No
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