Rapid fFN for the TLiIQ System, Fetal Fibronectin Enzyme Immunoassay
FDA premarket approval P920048/S013 · decided 2020-01-28
Approval details
- PMA number
- P920048
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Rapid fFN for the TLiIQ System, Fetal Fibronectin Enzyme Immunoassay
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Applicant
- Hologic, Inc.
- Date received
- 2018-01-02
- Decision date
- 2020-01-28
- Days to decision
- 756 days
- Decision code
- APPR
- Product code
- LKV
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- Approval for a new supplier of a critical component, A137 ascites, that is used in the manufacture of Rapid fFN for the TLiIQ System and Fetal Fibronectin Enzyme Immunoassay.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CoolSeal Generator® (CSL-200-90) (K253634) | Hologic, Inc. | 2026-06-17 |
| Panther Fusion GI Expanded Bacterial Assay (K251993) | Hologic, Inc. | 2025-09-25 |
| 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 |