Access Hybritech p2PSA Reagent Pack
FDA premarket approval P090026/S023 · decided 2019-01-09
Approval details
- PMA number
- P090026
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Access Hybritech p2PSA Reagent Pack
- Generic name
- P2psa
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2018-12-17
- Decision date
- 2019-01-09
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- OYA
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Chaska, MN
- Statement
- Change to the process for the Access p2PSA calibrator verification testing.
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