Clearance Summary
CardioChek Plus Test System, CardioChek Home Test System received FDA 510(k) clearance under submission number K162282, sponsored by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2016-12-22.
- Submission: K162282
- Applicant / Sponsor: Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2016-12-22
Classification & Regulation
This clearance is catalogued under FDA product code CGA and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.