DEN250046
- 510(k) number
- DEN250046
- Device name
- Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US)
- Applicant
- Vitestro NL
- Product code
- SIW not yet in the FDA classification database
- Decision date
- 2026-08-19
- Date received
- 2025-09-26
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Unknown
Official FDA record: DEN250046
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.