• 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 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 Namekit, test,alpha-fetoprotein for testicular cancer
Regulation Number866.6010
Abbott Laboratories
100 abbott park rd.
ap5n-2, dept. 09vb
abbott park, IL 60064-3500
PMA NumberP820060
Supplement NumberS013
Date Received07/02/1999
Decision Date02/02/2004
Product Code
LOJ[ Registered Establishments with LOJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the addition of the afp assay on the architect immunoassay instrument. The device, as modified, will be marketed under the trade name architect afp assay and is indicated for the quantitative determination of alpha-fetoprotein (afp) in : 1) human serum or plasma to aid in the management of patients with nonseminomatosus testicular cancer. 2) human serum, plasma, and amniotic fluid at 15 to 21 weeks gestation to aid in the detection of fetal open neural tube defects (ntd).