Rapid fFN for the TLiIQ System
FDA premarket approval P920048/S018 · decided 2020-10-02
Approval details
- PMA number
- P920048
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Rapid fFN for the TLiIQ System
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Applicant
- Hologic, Inc.
- Date received
- 2020-09-08
- Decision date
- 2020-10-02
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LKV
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- Addition of a manufacturing site at 10210 Genetic Center Dr., San Diego, CA 92121 (GCD) for the manufacture of critical components, proteins and protein conjugates, of the Rapid fFN cassette for theTLiIQ System.
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