Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceARCHITECT AFP
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantAbbott Laboratories
09v6 Ap5-2n
100 Abbott Park Rd.
Abbott Park, IL 60064
PMA NumberP120008
Supplement NumberS001
Date Received02/11/2013
Decision Date03/13/2013
Product Code LOK 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE AN IN-PROCESS QUALITY CONTROL TEST METHOD TO CONTINUE PRODUCTION OF THE ANTI-HBS NEGATIVE HUMAN PLASMAS USED IN THE MANUFACTURE OF THE ARCHITECT ASSAYS.
-
-