510(k) K220677
K220677 is an FDA 510(k) premarket notification submitted by Kurin, Inc. for the device "Kurin Blood Culture Collection Set with Kurin Lock Technology". The FDA issued a decision of Substantially Equivalent on Apr 28, 2023. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Kurin, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 28, 2023
- Date Received
- Mar 8, 2022
- 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
- 510(k)