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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 a medical device manufactured by Microgenics Corporation. It received FDA 510(k) clearance on 2018-02-21 under approval 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. It is manufactured by Microgenics Corporation. The 510(k) number is K173963.

When was DRI Benzodiazepine Assay approved by the FDA?

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

What company makes DRI Benzodiazepine Assay?

DRI Benzodiazepine Assay is manufactured by Microgenics Corporation.

What is the FDA product code for DRI Benzodiazepine Assay?

The FDA product code for DRI Benzodiazepine Assay is JXM.

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Related Devices (Code: JXM)

K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC K151771Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation K163590Psychemedics Microplate EIA for Benzodiazepines in HairPsychemedics Corporation K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC K190968CEDIA Benzodiazepine AssayMicrogenics Corporation K221765ONLINE DAT Benzodiazepines IIRoche Diagnostics

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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