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Device | ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS |
Generic Name | P2psa |
Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 |
PMA Number | P090026 |
Supplement Number | S015 |
Date Received | 05/07/2015 |
Decision Date | 06/23/2015 |
Product Code |
OYA |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES TO ALIGN WITH GLOBALLY HARMONIZEDSYSTEM OF CLASSIFICATION OF CHEMICALS (GHS) WHICH PROVIDES A CONSISTENT HAZARD CLASSIFICATION SYSTEM THAT IS RECOGNIZED GLOBALLY. |