K252899
- 510(k) number
- K252899
- Device name
- Female Culture Device; Male Culture Device; Transfer Device; Access Device
- Applicant
- Zhejiang Kindly Medical Device Co., Ltd. CN
- Product code
- JKA — Tubes, Vials, Systems, Serum Separators, Blood Colle
- Decision date
- 2026-06-02
- Date received
- 2025-09-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252899.pdf
Official FDA record: K252899
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.