Clearance Summary
MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 received FDA 510(k) clearance under submission number K063208, sponsored by Diagnostic Chemicals , Ltd.. 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 2007-01-19.
- Submission: K063208
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1495
- Decision date: 2007-01-19
Classification & Regulation
This clearance is catalogued under FDA product code JGJ and 21 CFR 862.1495, within the Clinical Chemistry review panel as a Class I device.