510(k) K171971
Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer by
Lite-On Technology Corp. H.S.P.B.
— Product Code CJE
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 2018
- Date Received
- June 30, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device Class
- Class II
- Regulation Number
- 862.1050
- Review Panel
- CH
- Submission Type