Emit 2000 Tacrolimus Assay and Sample Pretreatment Reagent

• • Terminated Z-1661-2018 FDA Class II ·initiated 29 Jun 2017

  Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.

510(k) Number

K060385 ↗

FDA Product Code

MLM

Device Class

Class II

Regulation

21 CFR Part 862.1678

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

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  Class I

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