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FDA 510(k)

Emit® II Plus Buprenorphine Assay

K-Number: K221605 · 2023-07-25

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2023-07-25
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Emit® II Plus Buprenorphine 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 2023-07-25 under 510(k) number K221605. 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 Buprenorphine Assay?

Emit® II Plus Buprenorphine Assay is a medical device that received FDA 510(k) clearance on 2023-07-25. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K221605.

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

Emit® II Plus Buprenorphine Assay received FDA 510(k) clearance on 2023-07-25, under 510(k) number K221605.

Who is the listed applicant for Emit® II Plus Buprenorphine 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 Buprenorphine Assay?

The FDA product code for Emit® II Plus Buprenorphine 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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