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FDA 510(k)

Emit II Plus Oxycodone Assay

K-Number: K172910 · 2017-10-18

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2017-10-18
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Emit II Plus Oxycodone 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 2017-10-18 under 510(k) number K172910. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Emit II Plus Oxycodone Assay?

Emit II Plus Oxycodone Assay is a medical device that received FDA 510(k) clearance on 2017-10-18. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K172910.

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

Emit II Plus Oxycodone Assay received FDA 510(k) clearance on 2017-10-18, under 510(k) number K172910.

Who is the listed applicant for Emit II Plus Oxycodone 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 Oxycodone Assay?

The FDA product code for Emit II Plus Oxycodone Assay is DJG.

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Related Devices (Code: DJG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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