PMA P090026S008
- Device
- ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P090026
- Supplement
- S008
- Product code
- OYA
- Decision date
- 2013-10-17
- Classification
- P2psa
- Generic name
- P2psa
- Approval order statement
- APPROVAL FOR THE ADDITION OF NEW WARNINGS TO THE ACCESS 2 INSTRUMENT MANUALS.
Current openFDA PMA Record#
- Device
- ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P090026
- Supplement
- S008
- Product code
- OYA
- Generic name
- P2psa
- Decision date
- 2013-10-17
- Decision code
- APPR
- Date received
- 2013-06-13
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE ADDITION OF NEW WARNINGS TO THE ACCESS 2 INSTRUMENT MANUALS.