Clearance Summary
Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer received FDA 510(k) clearance under submission number K171971, sponsored by Lite-On Technology Corp. H.S.P.B.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2018-01-25.
- Submission: K171971
- Applicant / Sponsor: Lite-On Technology Corp. H.S.P.B.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1050
- Decision date: 2018-01-25
Classification & Regulation
This clearance is catalogued under FDA product code CJE and 21 CFR 862.1050, within the Clinical Chemistry review panel as a Class II device.