Clearance Summary
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD received FDA 510(k) clearance under submission number K073604, sponsored by Dade Behring, Inc.. 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 2008-03-13.
- Submission: K073604
- Applicant / Sponsor: Dade Behring, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1695
- Decision date: 2008-03-13
Classification & Regulation
This clearance is catalogued under FDA product code CEC and 21 CFR 862.1695, within the Clinical Chemistry review panel as a Class II device.