• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePGR-EIA MONOCLONAL
Classification Namekit, assay, progesterone receptor
Generic Nameimmunoassay for measurement of progesterone rece
Regulation Number864.1860
ApplicantABBOTT LABORATORIES
PMA NumberP900013
Supplement NumberS002
Date Received09/16/1999
Decision Date09/22/1999
Product Code
LPI
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding "caution: this product contains natural dry rubber" to the labeling.
-
-