510(k) K233979
K233979 is an FDA 510(k) premarket notification submitted by Greiner Bio-One North America, Inc. for the device "VACUETTE® QUICKSHIELD Complete (Plus)". The FDA issued a decision of Substantially Equivalent on July 19, 2024. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Greiner Bio-One North America, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2024
- Date Received
- December 18, 2023
- 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