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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.
 
DeviceABBOTT PGR-EIA MONOCLONAL
Generic NameKIT, ASSAY, PROGESTERONE RECEPTOR
Regulation Number864.1860
ApplicantAbbott Laboratories
200 Abbott Park Rd.
Abbott Park, IL 60064
PMA NumberP900013
Supplement NumberS001
Date Received05/25/1995
Decision Date07/07/1995
Withdrawal Date07/26/2004
Product Code LPI 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MINOR LABELING CHANGES TO ASSIST USERS IN AVOIDING INTERFERENCE BY METHYLENE BLUE & SIMILAR DYES.CHANGES:REVISED INSTRUCTIONS ON SPECIMEN COLLECTION & SLIDE PREPARATION,ADDING REFERENCE ON THE EFFECT OF METHYLENE BLUE ON ESTROGEN RECEPTORS
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