Clearance Summary
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE received FDA 510(k) clearance under submission number K043546, sponsored by Dade Behring, Inc.. 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 2005-01-18.
- Submission: K043546
- Applicant / Sponsor: Dade Behring, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1705
- Decision date: 2005-01-18
Classification & Regulation
This clearance is catalogued under FDA product code CDT and 21 CFR 862.1705, within the Clinical Chemistry review panel as a Class I device.