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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 NameRIANEN 3H
Classification Namekit, assay, estrogen receptor
Generic Nameestrogen receptor assay, 3h
Regulation Number864.1860
PMA NumberP800061
Date Received10/22/1980
Decision Date06/01/1981
Withdrawal Date 02/07/2012
Product Code
Notice Date 07/14/1981
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009