Clearance Summary
PTS PANELS HDL CHOLESTEROL TEST STRIPS received FDA 510(k) clearance under submission number K060617, 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 2006-04-05.
- Submission: K060617
- Applicant / Sponsor: Polymer Technology Systems, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1175
- Decision date: 2006-04-05
Classification & Regulation
This clearance is catalogued under FDA product code NAQ and 21 CFR 862.1175, within the Clinical Chemistry review panel as a Class I device.