Clearance Summary
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 received FDA 510(k) clearance under submission number K000874, sponsored by Bio-Rad. 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 2000-04-18.
- Submission: K000874
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2000-04-18
Classification & Regulation
This clearance is catalogued under FDA product code JJW and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.