Cleared Traditional

ARCHITECT TACROLIMUS: MODEL 1L77

K070820 · Fujirebio Diagnostics,Inc. · Toxicology
Aug 2007
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K070820 is an FDA 510(k) clearance for the ARCHITECT TACROLIMUS: MODEL 1L77, a Enzyme Immunoassay, Tracrolimus (Class II — Special Controls, product code MLM), submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on August 1, 2007, 128 days after receiving the submission on March 26, 2007. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1678.

Submission Details

510(k) Number K070820 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2007
Decision Date August 01, 2007
Days to Decision 128 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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