K220458
- 510(k) number
- K220458
- Device name
- UltraFlo-R Push Button Blood Collection Set
- Applicant
- Innovative Medical Technologies, Inc. NE · US
- Product code
- JKA — Tubes, Vials, Systems, Serum Separators, Blood Colle
- Decision date
- 2023-09-29
- Date received
- 2022-02-17
- 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: K220458
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.