|
Device | ABBOTT AXSYM AFP (LIST 7A48) |
Generic Name | KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER |
Regulation Number | 866.6010 |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. AP5N-2, DEPT. 09VB ABBOTT PARK, IL 60064-3500 |
PMA Number | P820060 |
Supplement Number | S009 |
Date Received | 11/22/1995 |
Decision Date | 12/26/1995 |
Withdrawal Date
|
11/15/2013 |
Product Code |
LOJ |
Advisory Committee |
Immunology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MODIFICATION OF THE POTENCY TEST FOR THE ANTI-AFP: ALKALINE PHOSPHATASE CONJUGATE |