Rapid fFN for the TLiIQ System
FDA premarket approval P920048/S016 · decided 2020-09-03
Approval details
- PMA number
- P920048
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Rapid fFN for the TLiIQ System
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Applicant
- Hologic, Inc.
- Date received
- 2020-06-01
- Decision date
- 2020-09-03
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- LKV
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- Approval for a change to the grade of cellulose acetate used in the manufacturing of nitrocellulose at a supplier. Nitrocellulose is used in the assembly of Rapid fFN Cassettes for the TLiIQ System.
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