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FDA 510(k)

Alinity c Tricyclic Antidepressants Reagent Kit

K-Number: K231020 · 2023-11-17

ApplicantMicrogenics Corporation
Decision Date2023-11-17
Product CodeLFH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Alinity c Tricyclic Antidepressants Reagent Kit is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corporation. It received FDA 510(k) clearance on 2023-11-17 under 510(k) number K231020. 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 Alinity c Tricyclic Antidepressants Reagent Kit?

Alinity c Tricyclic Antidepressants Reagent Kit is a medical device that received FDA 510(k) clearance on 2023-11-17. The listed applicant is Microgenics Corporation. The 510(k) number is K231020.

When did Alinity c Tricyclic Antidepressants Reagent Kit receive FDA 510(k) clearance?

Alinity c Tricyclic Antidepressants Reagent Kit received FDA 510(k) clearance on 2023-11-17, under 510(k) number K231020.

Who is the listed applicant for Alinity c Tricyclic Antidepressants Reagent Kit?

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 Alinity c Tricyclic Antidepressants Reagent Kit?

The FDA product code for Alinity c Tricyclic Antidepressants Reagent Kit is LFH.

Other records listing Microgenics Corporation as applicant

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.

K243498Alinity c Benzodiazepines Reagent KitK240670DRI Ecstasy Plus AssayK231007CEDIA Heroin Metabolite (6-AM) AssayK213875DRI TM Tricyclics Serum Tox AssayK211973DRI Cocaine Metabolite AssayK192943CEDIA Heroin Metabolite (6-AM) assay

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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.

K213875DRI TM Tricyclics Serum Tox AssayMicrogenics Corporation

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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