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FDA 510(k)

DRI Benzodiazepine Assay

K-Number: K173963 · 2018-02-21

ApplicantMicrogenics Corporation
Decision Date2018-02-21
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRI Benzodiazepine 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 2018-02-21 under 510(k) number K173963. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRI Benzodiazepine Assay?

DRI Benzodiazepine Assay is a medical device that received FDA 510(k) clearance on 2018-02-21. The listed applicant is Microgenics Corporation. The 510(k) number is K173963.

When did DRI Benzodiazepine Assay receive FDA 510(k) clearance?

DRI Benzodiazepine Assay received FDA 510(k) clearance on 2018-02-21, under 510(k) number K173963.

Who is the listed applicant for DRI Benzodiazepine 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 Benzodiazepine Assay?

The FDA product code for DRI Benzodiazepine Assay is JXM.

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 AssayK231020Alinity c Tricyclic Antidepressants Reagent KitK231007CEDIA Heroin Metabolite (6-AM) AssayK213875DRI TM Tricyclics Serum Tox AssayK211973DRI Cocaine Metabolite Assay

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Related Devices (Code: JXM)

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 KitMicrogenics CorporationK221765ONLINE DAT Benzodiazepines IIRoche DiagnosticsK190968CEDIA Benzodiazepine AssayMicrogenics CorporationK163590Psychemedics Microplate EIA for Benzodiazepines in HairPsychemedics CorporationK163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLCK153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC

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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