Clearance Summary
EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT received FDA 510(k) clearance under submission number K060385, 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 2006-04-06.
- Submission: K060385
- Applicant / Sponsor: Dade Behring, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1678
- Decision date: 2006-04-06
Classification & Regulation
This clearance is catalogued under FDA product code MLM and 21 CFR 862.1678, within the Clinical Chemistry review panel as a Class II device.