Clearance Summary
CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY received FDA 510(k) clearance under submission number K981931, sponsored by Roche Diagnostics/Boehringer Mannheim GmbH. 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 1998-08-25.
- Submission: K981931
- Applicant / Sponsor: Roche Diagnostics/Boehringer Mannheim GmbH
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1295
- Decision date: 1998-08-25
Classification & Regulation
This clearance is catalogued under FDA product code CGN and 21 CFR 862.1295, within the Clinical Chemistry review panel as a Class II device.