Cleared Traditional

Elecsys Tacrolimus

K173857 · Roche Diagnostics · Toxicology
Nov 2018
Decision
321d
Days
Class 2
Risk

About This 510(k) Submission

K173857 is an FDA 510(k) clearance for the Elecsys Tacrolimus, a Enzyme Immunoassay, Tracrolimus (Class II — Special Controls, product code MLM), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on November 6, 2018, 321 days after receiving the submission on December 20, 2017. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1678.

Submission Details

510(k) Number K173857 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2017
Decision Date November 06, 2018
Days to Decision 321 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code MLM — Enzyme Immunoassay, Tracrolimus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1678

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