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Device | ACCESS HYBRITECH P2SA REAGENTS ON THE ACCESS IMMUNCASSAY SYSTEM |
Generic Name | P2psa |
Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 |
PMA Number | P090026 |
Supplement Number | S014 |
Date Received | 11/04/2014 |
Decision Date | 03/20/2015 |
Product Code |
OYA |
Advisory Committee |
Immunology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF AN ALTERNATE VENDOR OF THE POLYPROPYLENE RESIN USED TO MANUFACTURE THE UNICEL DXL REACTION VESSELS. |