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. |
|
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 | S007 |
Date Received | 01/18/2006 |
Decision Date | 01/30/2006 |
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 CHANGES TO THE ACCESS, ACCESS 2 AND SYNCHRON LXI 725 ANALYZER OPERATING SOFTWARE TO REMOVE THE DIL-AFP ASSAY PROTOCOL AND RESTORE THE SYSTEMS TO THEIR ORIGINAL FUNCTIONALITY. |
|
|