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FDA 510(k)

DRI Hydrocodone Assay

K-Number: K173195 · 2018-02-13

ApplicantMicrogenics Corporation
Decision Date2018-02-13
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRI Hydrocodone Assay is a medical device manufactured by Microgenics Corporation. It received FDA 510(k) clearance on 2018-02-13 under approval number K173195. 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 DRI Hydrocodone Assay?

DRI Hydrocodone Assay is a medical device that received FDA 510(k) clearance on 2018-02-13. It is manufactured by Microgenics Corporation. The 510(k) number is K173195.

When was DRI Hydrocodone Assay approved by the FDA?

DRI Hydrocodone Assay received FDA 510(k) clearance on 2018-02-13, under approval number K173195.

What company makes DRI Hydrocodone Assay?

DRI Hydrocodone Assay is manufactured by Microgenics Corporation.

What is the FDA product code for DRI Hydrocodone Assay?

The FDA product code for DRI Hydrocodone Assay is DJG.

Other Devices by Microgenics Corporation

K173183CEDIA Heroin Metabolite (6-AM) Assay K163101CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set DEN180030QMS Plazomicin Immunoassay K181499DRI Cocaine Metabolite Assay K173963DRI Benzodiazepine Assay K192943CEDIA Heroin Metabolite (6-AM) assay

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Related Devices (Code: DJG)

K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 TestsChemtron Biotech, Inc. K173183CEDIA Heroin Metabolite (6-AM) AssayMicrogenics Corporation K172910Emit II Plus Oxycodone AssaySiemens Healthcare Diagnostics, Inc. K161216Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine CalibratorsImmunalysis Corporation K163101CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control SetMicrogenics 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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