K213146
- 510(k) number
- K213146
- Device name
- Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen
- Applicant
- Jiangsu Rongye Technology Co., Ltd. CN
- Product code
- JKA — Tubes, Vials, Systems, Serum Separators, Blood Colle
- Decision date
- 2023-10-27
- Date received
- 2021-09-27
- 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: K213146
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.