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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.
 
DeviceFLUORO-CEP{R} ESTROGEN ASSAY REAGENT
Generic NameKIT, ASSAY, ESTROGEN RECEPTOR
Regulation Number864.1860
ApplicantZeus Technologies
P.O.Box 38
Raritan, NJ 08869
PMA NumberP860015
Supplement NumberS002
Date Received12/30/1991
Decision Date04/17/1992
Withdrawal Date03/26/2009
Product Code LPJ 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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