PMA P090026S011
- Device
- ACCESS HYBRITECH P2PSA ON TH ACCESS IMMNUNOASSAY SYSTEM
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P090026
- Supplement
- S011
- Product code
- OYA
- Decision date
- 2014-07-07
- Classification
- P2psa
- Generic name
- P2psa
- Approval order statement
- MODIFICATION TO THE QUALITY CONTROL PREFILL AND POSTFILL REAGENT PACK PROCEDURES.
Current openFDA PMA Record#
- Device
- ACCESS HYBRITECH P2PSA ON TH ACCESS IMMNUNOASSAY SYSTEM
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P090026
- Supplement
- S011
- Product code
- OYA
- Generic name
- P2psa
- Decision date
- 2014-07-07
- Decision code
- OK30
- Date received
- 2014-06-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION TO THE QUALITY CONTROL PREFILL AND POSTFILL REAGENT PACK PROCEDURES.