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FDA 510(k)

CEDIA Heroin Metabolite (6-AM) assay

K-Number: K192943 · 2019-12-16

ApplicantMicrogenics Corporation
Decision Date2019-12-16
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA Heroin Metabolite (6-AM) assay is a medical device manufactured by Microgenics Corporation. It received FDA 510(k) clearance on 2019-12-16 under approval number K192943. 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 CEDIA Heroin Metabolite (6-AM) assay?

CEDIA Heroin Metabolite (6-AM) assay is a medical device that received FDA 510(k) clearance on 2019-12-16. It is manufactured by Microgenics Corporation. The 510(k) number is K192943.

When was CEDIA Heroin Metabolite (6-AM) assay approved by the FDA?

CEDIA Heroin Metabolite (6-AM) assay received FDA 510(k) clearance on 2019-12-16, under approval number K192943.

What company makes CEDIA Heroin Metabolite (6-AM) assay?

CEDIA Heroin Metabolite (6-AM) assay is manufactured by Microgenics Corporation.

What is the FDA product code for CEDIA Heroin Metabolite (6-AM) assay?

The FDA product code for CEDIA Heroin Metabolite (6-AM) 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 K173195DRI Hydrocodone 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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