Clearance Summary
TRI-TECH URINE SPECIMEN KIT received FDA 510(k) clearance under submission number K900983, sponsored by Tri-Tech, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1990-09-17.
- Submission: K900983
- Applicant / Sponsor: Tri-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3250
- Decision date: 1990-09-17
Classification & Regulation
This clearance is catalogued under FDA product code FMH and 21 CFR 864.3250, within the Pathology review panel as a Class I device.