• 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.
Classification Namekit, test, alpha-fetoprotein for neural tube defects
PMA NumberP010007
Supplement NumberS001
Date Received01/21/2003
Decision Date02/24/2003
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of the immulite afp on the immulite 1000 automated analyzer. The device, as modified, will be marketed under the trade name immulite/ immulite 1000 afp and is indicated: for in vitro diagnostic use with the immulite and immulte 1000 analyzers - for the quantitative measurement of alpha-fetoprotein (afp) in either of two contexts: (a) serial measurements in human serum to aid in the management of patients with nonseminomatous testicular cancer; or (b) measurements in maternal serum and amniotic fluid during gestational weeks 15 through 20 - used in conjunction with ultrasonography or amniography - to aid in detection of fetal open neural tube defects.