510(k) K173857
K173857 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Tacrolimus". The FDA issued a decision of Substantially Equivalent on November 6, 2018. The device falls under product code MLM (Enzyme Immunoassay, Tracrolimus), a Class II device regulated under 21 CFR 862.1678. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 2018
- Date Received
- December 20, 2017
- 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