Clearance Summary
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH received FDA 510(k) clearance under submission number K063608, 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 2007-02-23.
- Submission: K063608
- Applicant / Sponsor: Dade Behring, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 2007-02-23
Classification & Regulation
This clearance is catalogued under FDA product code MSJ and 21 CFR 862.1475, within the Clinical Chemistry review panel as a Class I device.