• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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.
 
Trade NameADVIA CENTAUR AFP ASSAY
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Nameafp immunoassy
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
PMA NumberP930036
Supplement NumberS005
Date Received03/26/2012
Decision Date10/15/2012
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at stratec biomedical switzerland ag in beringen, switzerland.
-
-