Cleared Traditional

Emit II Plus Cocaine Metabolite Assay

K170293 · Siemens Healthcare Diagnostics, Inc. · Toxicology
Oct 2017
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K170293 is an FDA 510(k) clearance for the Emit II Plus Cocaine Metabolite Assay, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on October 25, 2017, 267 days after receiving the submission on January 31, 2017. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K170293 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2017
Decision Date October 25, 2017
Days to Decision 267 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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