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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 a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-07-25 under approval 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. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K221605.

When was Emit® II Plus Buprenorphine Assay approved by the FDA?

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

What company makes Emit® II Plus Buprenorphine Assay?

Emit® II Plus Buprenorphine Assay is manufactured by Siemens Healthcare Diagnostics, Inc..

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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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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