FDA 510(k)

Emit II Plus Cocaine Metabolite Assay

K-Number: K170293 · 2017-10-25

ApplicantSiemens Healthcare Diagnostics, Inc.

Decision Date2017-10-25

Product CodeDIO

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

Emit II Plus Cocaine Metabolite Assay is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-10-25 under 510(k) number K170293. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Emit II Plus Cocaine Metabolite Assay?

Emit II Plus Cocaine Metabolite Assay is a medical device that received FDA 510(k) clearance on 2017-10-25. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K170293.

When did Emit II Plus Cocaine Metabolite Assay receive FDA 510(k) clearance?

Emit II Plus Cocaine Metabolite Assay received FDA 510(k) clearance on 2017-10-25, under 510(k) number K170293.

Who is the listed applicant for Emit II Plus Cocaine Metabolite Assay?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Emit II Plus Cocaine Metabolite Assay?

The FDA product code for Emit II Plus Cocaine Metabolite Assay is DIO.

Other records listing Siemens Healthcare Diagnostics, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.