Clearance Summary
ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 received FDA 510(k) clearance under submission number K100293, sponsored by Siemens Heatlhcare Diagnostics, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2010-03-19.
- Submission: K100293
- Applicant / Sponsor: Siemens Heatlhcare Diagnostics, Inc.
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 2010-03-19
Classification & Regulation
This clearance is catalogued under FDA product code JIT and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.