510(k) K060385
K060385 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT". The FDA issued a decision of Substantially Equivalent on April 6, 2006. The device falls under product code MLM (Enzyme Immunoassay, Tracrolimus), a Class II device regulated under 21 CFR 862.1678. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 2006
- Date Received
- February 14, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Tracrolimus
- Device Class
- Class II
- Regulation Number
- 862.1678
- Review Panel
- TX
- Submission Type