Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System
FDA premarket approval P920048/S027 · decided 2024-12-06
Approval details
- PMA number
- P920048
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Applicant
- Hologic, Inc.
- Date received
- 2024-11-07
- Decision date
- 2024-12-06
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LKV
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- to add a new supplier for a component of the quality control and calibrator materials used for the Rapid fFN Control Kit and Rapid fFN for the TLiIQ System
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