PMA P090026S021
- Device
- Access Hybritech p2PSA Reagents on the Access Immunoassay System
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P090026
- Supplement
- S021
- Product code
- OYA
- Decision date
- 2017-10-24
- Classification
- P2psa
- Generic name
- P2psa
- Approval order statement
- Addition of a supplier manufacturing site for the production of the UniCel DxI reaction vessels.
Current openFDA PMA Record#
- Device
- Access Hybritech p2PSA Reagents on the Access Immunoassay System
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P090026
- Supplement
- S021
- Product code
- OYA
- Generic name
- P2psa
- Decision date
- 2017-10-24
- Decision code
- OK30
- Date received
- 2017-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a supplier manufacturing site for the production of the UniCel DxI reaction vessels.