Origin™
FDA 510(k) clearance K243965 · decided 2025-08-21
Clearance details
- K-number
- K243965
- Device name
- Origin™
- Applicant
- Nerv Technology Inc. (D.B.A.) Fluidai Medical
- Decision
- Substantially Equivalent
- Date received
- 2024-12-23
- Decision date
- 2025-08-21
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- SFO
- Device class
- 2
- Regulation number
- 862.1120
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Kitchener, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.