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. |
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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 | S010 |
Date Received | 11/15/1996 |
Decision Date | 12/02/1996 |
Withdrawal Date
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11/15/2013 |
Product Code |
LOJ |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MOVING THE NORMAL MOUSE SERUM CONTAINED IN THE CONJUGATE COMPONENT TO THE ASSAY DILUENT COMPONENT |
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