Rapid fFN for the TLilQ System
FDA premarket approval P920048/S020 · decided 2021-04-29
Approval details
- PMA number
- P920048
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Rapid fFN for the TLilQ System
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Applicant
- Hologic, Inc.
- Date received
- 2021-04-09
- Decision date
- 2021-04-29
- Days to decision
- 20 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 (GCD) for the manufacture of critical components of the Rapid fFN for the TLiIQ System, namely the control kit, calibrators and other internal use-only components.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CoolSeal Generator® (CSL-200-90) (K253634) | Hologic, Inc. | 2026-06-17 |
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| Genius AI Detection 2.0 (K243341) | Hologic, Inc. | 2025-07-31 |
| Aptima SARS-CoV-2 Assay (K243396) | Hologic, Inc. | 2025-02-13 |
| Aptima CMV Quant Assay (K243935) | Hologic, Inc. | 2025-01-17 |
| Aptima BV Assay; Aptima CV/TV Assay (K243345) | Hologic, Inc. | 2024-11-25 |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (K242465) | Hologic, Inc. | 2024-11-15 |
| Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) (K240886) | Hologic, Inc. | 2024-07-25 |