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 ARCHITECT 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 | S023 |
Date Received | 10/03/2007 |
Decision Date | 05/21/2008 |
Withdrawal Date
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11/15/2013 |
Product Code |
LOK |
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: 1) CREATION OF AFP WHO PRIMARY CALIBRATORS AND CONTROLS; 2) ASSAY SOFTWARE CHANGES: A) VOLUME OF SAMPLE IN THE PIPETTING PROTOCOL; B) DILUTION OF SPECIMEN IN THE AUTOMATED DILUTION PROTOCOLS; AND C) DILUTION PARAMETERS; 3) MANUAL DILUENT CHANGE; AND 4) NEW CONTROL CONCENTRATIONS. |
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