Clearance Summary
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE received FDA 510(k) clearance under submission number K061020, 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 2006-05-10.
- Submission: K061020
- Applicant / Sponsor: Dade Behring, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1030
- Decision date: 2006-05-10
Classification & Regulation
This clearance is catalogued under FDA product code CKA and 21 CFR 862.1030, within the Clinical Chemistry review panel as a Class I device.