Clearance Summary
MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) received FDA 510(k) clearance under submission number K993377, sponsored by Polymer Technology Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2000-01-13.
- Submission: K993377
- Applicant / Sponsor: Polymer Technology Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1175
- Decision date: 2000-01-13
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.