PMA P090026S016
- Device
- ACCESS P2PSA CALIBRATOR ON THE ACCESS IMMUNOASSAY ANALYZER
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P090026
- Supplement
- S016
- Product code
- OYA
- Decision date
- 2017-02-14
- Classification
- P2psa
- Generic name
- P2psa
- Approval order statement
- Add another filling line for the filling, sealing, and labeling of calibrator bottles using the new Bottle/Vial Filler.
Current openFDA PMA Record#
- Device
- ACCESS P2PSA CALIBRATOR ON THE ACCESS IMMUNOASSAY ANALYZER
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P090026
- Supplement
- S016
- Product code
- OYA
- Generic name
- P2psa
- Decision date
- 2017-02-14
- Decision code
- OK30
- Date received
- 2017-01-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add another filling line for the filling, sealing, and labeling of calibrator bottles using the new Bottle/Vial Filler.