Clearance Summary
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 received FDA 510(k) clearance under submission number K093631, sponsored by Siemens Healthcare Diagnostics. 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 2010-02-12.
- Submission: K093631
- Applicant / Sponsor: Siemens Healthcare Diagnostics
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1810
- Decision date: 2010-02-12
Classification & Regulation
This clearance is catalogued under FDA product code CDD and 21 CFR 862.1810, within the Clinical Chemistry review panel as a Class II device.