|
Device | ARCHITECT AFP / Alinity i AFP |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | Abbott Laboratories 09V6 AP5-2N 100 ABBOTT PARK ROAD ABBOTT PARK, IL 60064 |
PMA Number | P120008 |
Supplement Number | S020 |
Date Received | 09/14/2022 |
Decision Date | 10/12/2022 |
Product Code |
LOK |
Advisory Committee |
Immunology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Add an additional supplier for a kit component. |