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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceRIANEN I125
Classification Namekit, assay, estrogen receptor
Generic Namekit, assay, estrogen receptor
Regulation Number864.1860
4417 lancaster pike
wilmington, DE 19805
PMA NumberP800061
Supplement NumberS001
Date Received10/22/1980
Decision Date06/02/1981
Product Code
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No