Rapid fFN for the TLiIQ System
FDA premarket approval P920048/S019 · decided 2021-05-21
Approval details
- PMA number
- P920048
- Supplement
- S019
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Rapid fFN for the TLiIQ System
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Applicant
- Hologic, Inc.
- Date received
- 2020-10-30
- Decision date
- 2021-05-21
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- LKV
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- Approval for a manufacturing site located at 10210 Genetic Center Dr., San Diego, CA 92121 (GCD), for the manufacture of finished, kitted Rapid fFN Cassettes for use in the TLiIQ System.
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