510(k) K131189
K131189 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)". The FDA issued a decision of Substantially Equivalent on April 17, 2014. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2014
- Date Received
- April 26, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hexokinase, Glucose
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type