Clearance Summary
TOTAL PROTEIN URINE/CSF GEN.3 received FDA 510(k) clearance under submission number K141925, sponsored by Roche Diagnostics Operations (Rdo). The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2014-12-09.
- Submission: K141925
- Applicant / Sponsor: Roche Diagnostics Operations (Rdo)
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1645
- Decision date: 2014-12-09
Classification & Regulation
This clearance is catalogued under FDA product code JIQ and 21 CFR 862.1645, within the Clinical Chemistry review panel as a Class I device.