Clearance Summary
ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773 received FDA 510(k) clearance under submission number K091867, sponsored by Siemens Healthcare Diagnostics. 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 2010-01-14.
- Submission: K091867
- Applicant / Sponsor: Siemens Healthcare Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1680
- Decision date: 2010-01-14
Classification & Regulation
This clearance is catalogued under FDA product code CDZ and 21 CFR 862.1680, within the Clinical Chemistry review panel as a Class I device.