Clearance Summary
URIC ACID (TPTZ) COLORINMETRIC received FDA 510(k) clearance under submission number K810088, sponsored by Bio-Analytics Laboratories, 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 1981-01-28.
- Submission: K810088
- Applicant / Sponsor: Bio-Analytics Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1775
- Decision date: 1981-01-28
Classification & Regulation
This clearance is catalogued under FDA product code CDH and 21 CFR 862.1775, within the Clinical Chemistry review panel as a Class I device.