Clearance Summary
Multichem IA Plus received FDA 510(k) clearance under submission number K162530, sponsored by Techno-Path Manufacturing. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2017-03-31.
- Submission: K162530
- Applicant / Sponsor: Techno-Path Manufacturing
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2017-03-31
Classification & Regulation
This clearance is catalogued under FDA product code JJY and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.