PMA P090026S023
- Device
- Access Hybritech p2PSA Reagent Pack
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P090026
- Supplement
- S023
- Product code
- OYA
- Decision date
- 2019-01-09
- Classification
- P2psa
- Generic name
- P2psa
- Approval order statement
- Change to the process for the Access p2PSA calibrator verification testing.
Current openFDA PMA Record#
- Device
- Access Hybritech p2PSA Reagent Pack
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P090026
- Supplement
- S023
- Product code
- OYA
- Generic name
- P2psa
- Decision date
- 2019-01-09
- Decision code
- OK30
- Date received
- 2018-12-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the process for the Access p2PSA calibrator verification testing.