510(k) K252899
K252899 is an FDA 510(k) premarket notification submitted by Zhejiang Kindly Medical Device Co., Ltd. for the device "Female Culture Device; Male Culture Device; Transfer Device; Access Device". The FDA issued a decision of Substantially Equivalent on June 2, 2026. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Zhejiang Kindly Medical Device Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 2026
- Date Received
- September 11, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type