Cleared Traditional

CEDIA TACROLIMUS ASSAY

K050206 · Microgenics Corp. · Toxicology
Mar 2005
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K050206 is an FDA 510(k) clearance for the CEDIA TACROLIMUS ASSAY, a Enzyme Immunoassay, Tracrolimus (Class II — Special Controls, product code MLM), submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on March 15, 2005, 46 days after receiving the submission on January 28, 2005. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1678.

Submission Details

510(k) Number K050206 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2005
Decision Date March 15, 2005
Days to Decision 46 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

Similar Devices — MLM Enzyme Immunoassay, Tracrolimus

All 8
Tacrolimus Assay Kit
K203833 · Shanghai Genext Medical Technology Co., Ltd. · Jan 2023
Elecsys Tacrolimus
K173857 · Roche Diagnostics · Nov 2018
Dimension Tacrolimus Flex? Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
K150168 · Siemens Healthcare Diagnostics · Nov 2015
THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
K123343 · Microgenics Corp. · Jul 2013
ARCHITECT TACROLIMUS: MODEL 1L77
K070820 · Fujirebio Diagnostics,Inc. · Aug 2007
MASSTRAK IMMUNOSUPPRESSANTS KIT
K063868 · Waters Corporation · May 2007