Clearance Summary
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844 received FDA 510(k) clearance under submission number K981883, sponsored by Boehringer Mannheim Corp.. 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 1998-07-07.
- Submission: K981883
- Applicant / Sponsor: Boehringer Mannheim Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1110
- Decision date: 1998-07-07
Classification & Regulation
This clearance is catalogued under FDA product code CIG and 21 CFR 862.1110, within the Clinical Chemistry review panel as a Class II device.