Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DRI Cocaine Metabolite Assay

K-Number: K181499 · 2018-07-06

ApplicantMicrogenics Corporation
Decision Date2018-07-06
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRI Cocaine Metabolite 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 2018-07-06 under 510(k) number K181499. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRI Cocaine Metabolite Assay?

DRI Cocaine Metabolite Assay is a medical device that received FDA 510(k) clearance on 2018-07-06. The listed applicant is Microgenics Corporation. The 510(k) number is K181499.

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

DRI Cocaine Metabolite Assay received FDA 510(k) clearance on 2018-07-06, under 510(k) number K181499.

Who is the listed applicant for DRI Cocaine Metabolite 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 Cocaine Metabolite Assay?

The FDA product code for DRI Cocaine Metabolite Assay is DIO.

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

View all 13 devices →

Related Devices (Code: DIO)

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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.K211973DRI Cocaine Metabolite AssayMicrogenics CorporationK191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DXK170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries CorporationK162395MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupMp Biomedicals, 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.

↑