Elecsys sFlt-1 and Elecsys PlGF
FDA 510(k) clearance K241453 · decided 2025-02-07
Clearance details
- K-number
- K241453
- Device name
- Elecsys sFlt-1 and Elecsys PlGF
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2024-05-22
- Decision date
- 2025-02-07
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- QWH
- Device class
- 2
- Regulation number
- 862.1602
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System (DEN220027) | Brahms GmbH, Part of Thermo Fisher Scientific | 2023-05-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |