twiist system
FDA 510(k) clearance K250930 · decided 2025-04-02
Clearance details
- K-number
- K250930
- Device name
- twiist system
- Applicant
- Deka Research & Development Corp.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-28
- Decision date
- 2025-04-02
- Days to decision
- 5 days
- Clearance type
- Special
- Product code
- QFG
- Device class
- 2
- Regulation number
- 880.5730
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Manchester, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.