• 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.
 
DeviceABBOTT AXSYM AFP
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Namekit, test, alpha-fetoprotein for neural tube defects
Applicant
Abbott Laboratories
100 abbott park rd.
ap5n-2, dept. 09vb
abbott park, IL 60064-3500
PMA NumberP820060
Supplement NumberS022
Date Received08/21/2007
Decision Date03/26/2008
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for re-standardization of the manufacturing process for axsym afp calibrators and controls against the world health organization (who) first international standard 72/225 or alpha-fetoprotein (afp).
-
-