510(k) K083680
VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 by
Ortho-Clinical Diagnostics, Inc.
— Product Code CEM
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 2009
- Date Received
- December 12, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion Specific, Potassium
- Device Class
- Class II
- Regulation Number
- 862.1600
- Review Panel
- CH
- Submission Type