Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 ER-EIA MONOCLONAL DIAG. KIT
Generic NameKIT, ASSAY, ESTROGEN RECEPTOR
Regulation Number864.1860
ApplicantAbbott Laboratories
200 ABBOTT PARK RD.
ABBOTT PARK,, IL 60064-3537
PMA NumberP850029
Supplement NumberS001
Date Received05/25/1995
Decision Date07/12/1995
Withdrawal Date 10/15/2003
Product Code LPJ 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
MINOR LABELING CHGS TO ASSIST USERS TO AVOID INTERFERENCE BY METHYLENE BLUE & SIMILAR DYES.CHANGES:REVISED INSTRUCTIONS ON SPECIMEN COLLECTION & SLIDE PREPARATION, INSTRUCTIONS TO REPORT PRESENCE OR ABSENCE OF SURGICAL DYES
-
-