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 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 | S019 |
Date Received | 06/09/2017 |
Decision Date | 07/07/2017 |
Product Code |
OYA |
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 Manufacturing change to update a specification to allow for a limited amount of flash local to the gate location (where plastic material is injected into the reaction vessel) for the Access 2 Reaction Vessels, which are used during the processing of the assays. |
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