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 NEURAL TUBE DEFECTS |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. AP5N-2, DEPT. 09VB ABBOTT PARK, IL 60064-3500 |
PMA Number | P820060 |
Supplement Number | S029 |
Date Received | 04/21/2011 |
Decision Date | 05/12/2011 |
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 CHANGE THE SPECIFICATIONS FOR IN- PROCESS TESTING AND CUSTOMER RELEASE TESTING FOR AXSYM AFP AS A RESULT OF AN INTERNAL REVIEW OF THE PRODUCT RELATIVE TO UPDATED SPECIFICATION SETTING PROCEDURES. |
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