K251812
- 510(k) number
- K251812
- Device name
- Steripath® Flow Blood Collection System
- Applicant
- Magnolia Medical Technologies WA · US
- Product code
- JKA — Tubes, Vials, Systems, Serum Separators, Blood Colle
- Decision date
- 2025-09-25
- Date received
- 2025-06-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K251812
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.