• 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 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.
 
DeviceABBOTT ER-EIA MONOCLONAL DIAG. KIT
Classification Namekit, assay, estrogen receptor
Generic Namekit, assay, estrogen receptor
Regulation Number864.1860
Applicant
Abbott Laboratories
200 abbott park rd.
abbott park,, IL 60064-3537
PMA NumberP850029
Date Received05/17/1985
Decision Date10/17/1988
Withdrawal Date 10/15/2003
Product Code
LPJ
Docket Number 88M-0368
Notice Date 12/16/1988
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 
-
-