Clearance Summary
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE received FDA 510(k) clearance under submission number K062316, 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 2006-09-06.
- Submission: K062316
- Applicant / Sponsor: Dade Behring, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1065
- Decision date: 2006-09-06
Classification & Regulation
This clearance is catalogued under FDA product code JIF and 21 CFR 862.1065, within the Clinical Chemistry review panel as a Class I device.