TLiIQ QCette
FDA premarket approval P920048/S026 · decided 2024-10-23
Approval details
- PMA number
- P920048
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TLiIQ QCette
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Applicant
- Hologic, Inc.
- Date received
- 2024-09-27
- Decision date
- 2024-10-23
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LKV
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- to add a new supplier for the printed TLiIQ QCette strip for TLiIQ QCette. The TLiIQ QCette is a component of the Rapid fFN for the TLiIQ System
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510(k) clearances by this applicant
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