510(k) K182072
K182072 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides". The FDA issued a decision of Substantially Equivalent on October 30, 2018. The device falls under product code CGZ (Electrode, Ion-Specific, Chloride), a Class II device regulated under 21 CFR 862.1170. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2018
- Date Received
- August 1, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion-Specific, Chloride
- Device Class
- Class II
- Regulation Number
- 862.1170
- Review Panel
- CH
- Submission Type