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 | AXSYM AFP (LN 7A48) |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. AP5N-2, DEPT. 09VB ABBOTT PARK, IL 60064-3500 |
PMA Number | P820060 |
Supplement Number | S025 |
Date Received | 09/27/2010 |
Decision Date | 10/20/2010 |
Withdrawal Date
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11/15/2013 |
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 MODIFICATION TO A COMMON ACCESSORY FOR AXSYM ASSAYS. |
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