Clearance Summary
Multichem A1c received FDA 510(k) clearance under submission number K162514, sponsored by Technopath 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 2016-10-26.
- Submission: K162514
- Applicant / Sponsor: Technopath Manufacturing
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2016-10-26
Classification & Regulation
This clearance is catalogued under FDA product code JJX and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.