Clearance Summary
CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM received FDA 510(k) clearance under submission number K140068, sponsored by Polymer Technology Systems, Inc.. 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 2015-05-22.
- Submission: K140068
- Applicant / Sponsor: Polymer Technology Systems, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2015-05-22
Classification & Regulation
This clearance is catalogued under FDA product code NBW and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.