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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.
Classification Namekit, assay, estrogen receptor
Generic Namekit, assay, estrogen receptor
Regulation Number864.1860
4417 lancaster pike
wilmington, DE 19805
PMA NumberP800061
Supplement NumberS005
Date Received11/15/1982
Decision Date01/24/1983
Product Code
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No