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 |
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 | S012 |
Date Received | 10/15/1997 |
Decision Date | 10/29/1997 |
Withdrawal Date
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11/15/2013 |
Product Code |
LOJ |
Advisory Committee |
Immunology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes in the labeling regarding limitations of the procedure |
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