ACCESS HYBRITECH P2PSA ON TH ACCESS IMMNUNOASSAY SYSTEM
FDA premarket approval P090026/S011 · decided 2014-07-07
Approval details
- PMA number
- P090026
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACCESS HYBRITECH P2PSA ON TH ACCESS IMMNUNOASSAY SYSTEM
- Generic name
- P2psa
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2014-06-12
- Decision date
- 2014-07-07
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- OYA
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Chaska, MN
- Statement
- MODIFICATION TO THE QUALITY CONTROL PREFILL AND POSTFILL REAGENT PACK PROCEDURES.
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