B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System
FDA 510(k) clearance DEN220027 · decided 2023-05-18
Clearance details
- K-number
- DEN220027
- Device name
- B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System
- Applicant
- Brahms GmbH, Part of Thermo Fisher Scientific
- Decision
- Unknown
- Date received
- 2022-05-02
- Decision date
- 2023-05-18
- Days to decision
- 381 days
- Clearance type
- Direct
- Product code
- QWH
- Device class
- 2
- Regulation number
- 862.1602
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hennigsdorf, DE
- 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 |
|---|---|---|
| Elecsys sFlt-1 and Elecsys PlGF (K241453) | Roche Diagnostics | 2025-02-07 |
Recalls involving this device
No recalls on record reference this clearance.