Clearance Summary
MULTICHEM IA AND IA PLUS received FDA 510(k) clearance under submission number K132091, sponsored by Techno-Path Manufacturing , Ltd.. 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 2013-09-20.
- Submission: K132091
- Applicant / Sponsor: Techno-Path Manufacturing , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2013-09-20
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.