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FDA 510(k)

DRI TM Tricyclics Serum Tox Assay

K-Number: K213875 · 2022-12-21

ApplicantMicrogenics Corporation
Decision Date2022-12-21
Product CodeLFH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRI TM Tricyclics Serum Tox Assay is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corporation. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K213875. The device is classified under product code LFH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRI TM Tricyclics Serum Tox Assay?

DRI TM Tricyclics Serum Tox Assay is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Microgenics Corporation. The 510(k) number is K213875.

When did DRI TM Tricyclics Serum Tox Assay receive FDA 510(k) clearance?

DRI TM Tricyclics Serum Tox Assay received FDA 510(k) clearance on 2022-12-21, under 510(k) number K213875.

Who is the listed applicant for DRI TM Tricyclics Serum Tox Assay?

The FDA 510(k) record lists Microgenics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRI TM Tricyclics Serum Tox Assay?

The FDA product code for DRI TM Tricyclics Serum Tox Assay is LFH.

Other records listing Microgenics Corporation as applicant

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Related Devices (Code: LFH)

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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