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 | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P980041 |
Supplement Number | S016 |
Date Received | 12/23/2011 |
Decision Date | 02/17/2012 |
Product Code |
LOK |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE CHANGE IN POLYPROPYLENE RESIN USED FOR MANUFACTURING OF THE REAGENT PACK CONTAINER. |
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