• 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 | 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.
Classification Namekit, test,alpha-fetoprotein for testicular cancer
Generic Nameafp-eia diagnostic kit
Regulation Number866.6010
PMA NumberP820060
Supplement NumberS015
Date Received09/10/2002
Decision Date09/12/2002
Product Code
LOJ[ Registered Establishments with LOJ ]
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add a quality control test which will be performed after the reagent pack is packaged.