Clearance Summary
PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 received FDA 510(k) clearance under submission number K100130, sponsored by Mitsubishi Chemical Medience CO. 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 2011-05-16.
- Submission: K100130
- Applicant / Sponsor: Mitsubishi Chemical Medience CO
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 2011-05-16
Classification & Regulation
This clearance is catalogued under FDA product code MMI and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.