510(k) K220799
K220799 is an FDA 510(k) premarket notification submitted by Sb-Kawasumi Laboratories, Inc. for the device "K-SHIELD Zen". The FDA issued a decision of Substantially Equivalent on August 29, 2022. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Sb-Kawasumi Laboratories, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2022
- Date Received
- March 18, 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