FDA 510(k)

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES

K-Number: K131128 · 2013-11-13

Decision Date2013-11-13

Product CodeDIO

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES is the device name listed in this FDA 510(k) record. The listed applicant is Omega Laboratories, Inc.. It received FDA 510(k) clearance on 2013-11-13 under 510(k) number K131128. 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 OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES?

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES is a medical device that received FDA 510(k) clearance on 2013-11-13. The listed applicant is Omega Laboratories, Inc.. The 510(k) number is K131128.

When did OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES receive FDA 510(k) clearance?

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES received FDA 510(k) clearance on 2013-11-13, under 510(k) number K131128.

Who is the listed applicant for OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES?

The FDA 510(k) record lists Omega Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES?

The FDA product code for OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES is DIO.

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Other records listing Omega Laboratories, Inc. as applicant

K131181OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE K122759OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)K112808OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES K103161OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES K101973OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)K101059OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE

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Related Devices (Code: DIO)

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.K211973DRI Cocaine Metabolite AssayMicrogenics Corporation K191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DX K181499DRI Cocaine Metabolite AssayMicrogenics Corporation K170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries 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.