Rapid fFN for the TLilQ System
FDA premarket approval P920048/S024 · decided 2023-08-24
Approval details
- PMA number
- P920048
- Supplement
- S024
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Rapid fFN for the TLilQ System
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Applicant
- Hologic, Inc.
- Date received
- 2023-07-31
- Decision date
- 2023-08-24
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LKV
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- Approval of a labeling update to provide additional clarity on the specimen collection by indicating that, Only results from specimens obtained during a speculum examination are valid. Results from specimens obtained in any other manner, for example, vaginal examination, are invalid.
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510(k) clearances by this applicant
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