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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Namekit, assay, estrogen receptor
Generic Namekit, assay, estrogen receptor
Regulation Number864.1860
p.o. box 38
raritan, NJ 08869
PMA NumberP860015
Date Received04/28/1986
Decision Date02/29/1988
Withdrawal Date 03/26/2009
Product Code
Docket Number 88M-0091
Notice Date 05/11/1988
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002