510(k) K171059
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 2017
- Date Received
- April 10, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion Based, Enzymatic, Creatinine
- Device Class
- Class II
- Regulation Number
- 862.1225
- Review Panel
- CH
- Submission Type