Clearance Summary
COLORMATE TLC BILITEST SYSTEM received FDA 510(k) clearance under submission number K001687, sponsored by Chromatics Color Sciences Intl., 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 2001-09-13.
- Submission: K001687
- Applicant / Sponsor: Chromatics Color Sciences Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1113
- Decision date: 2001-09-13
Classification & Regulation
This clearance is catalogued under FDA product code MQM and 21 CFR 862.1113, within the Clinical Chemistry review panel as a Class I device.