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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 a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-10-25 under approval 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. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K170293.

When was Emit II Plus Cocaine Metabolite Assay approved by the FDA?

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

What company makes Emit II Plus Cocaine Metabolite Assay?

Emit II Plus Cocaine Metabolite Assay is manufactured by Siemens Healthcare Diagnostics, Inc..

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.

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Official Source

View on FDA Database →

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

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