510(k) K182078
K182078 is an FDA 510(k) premarket notification submitted by Greiner Bio-One Na, Inc. for the device "MiniCollect K2E K2EDTA Tubes". The FDA issued a decision of Substantially Equivalent on Jan 25, 2019. 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 Na, Inc. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 25, 2019
- Date Received
- Aug 2, 2018
- 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)