ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
FDA premarket approval P090026/S009 · decided 2013-10-17
Approval details
- PMA number
- P090026
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Generic name
- P2psa
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2013-09-26
- Decision date
- 2013-10-17
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- OYA
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Chaska, MN
- Statement
- APPROVAL FOR THE ADDITION OF PERIODIC REBOOTS IN THE MAINTENANCE SCHEDULE AND REVISING THE MAINTENANCE INSTRUCTIONS FOR THE UNICELDXI IMMUNOASSAY SYSTEMS.
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