Cleared Traditional

Dimension Tacrolimus Flex? Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)

K150168 · Siemens Healthcare Diagnostics · Toxicology
Nov 2015
Decision
282d
Days
Class 2
Risk

About This 510(k) Submission

K150168 is an FDA 510(k) clearance for the Dimension Tacrolimus Flex? Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL), a Enzyme Immunoassay, Tracrolimus (Class II — Special Controls, product code MLM), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on November 4, 2015, 282 days after receiving the submission on January 26, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1678.

Submission Details

510(k) Number K150168 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2015
Decision Date November 04, 2015
Days to Decision 282 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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