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FDA 510(k)

COZART EIA COCAINE ORAL FLIUD KIT

K-Number: K030234 · 2003-04-28

ApplicantCozart Bioscience , Ltd.
Decision Date2003-04-28
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COZART EIA COCAINE ORAL FLIUD KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cozart Bioscience , Ltd.. It received FDA 510(k) clearance on 2003-04-28 under 510(k) number K030234. 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 COZART EIA COCAINE ORAL FLIUD KIT?

COZART EIA COCAINE ORAL FLIUD KIT is a medical device that received FDA 510(k) clearance on 2003-04-28. The listed applicant is Cozart Bioscience , Ltd.. The 510(k) number is K030234.

When did COZART EIA COCAINE ORAL FLIUD KIT receive FDA 510(k) clearance?

COZART EIA COCAINE ORAL FLIUD KIT received FDA 510(k) clearance on 2003-04-28, under 510(k) number K030234.

Who is the listed applicant for COZART EIA COCAINE ORAL FLIUD KIT?

The FDA 510(k) record lists Cozart Bioscience , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COZART EIA COCAINE ORAL FLIUD KIT?

The FDA product code for COZART EIA COCAINE ORAL FLIUD KIT is DIO.

Related Clinical Trials

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Other records listing Cozart Bioscience , Ltd. 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.

K033743COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KITK021944COZART EIA COTININE URINE KITK024339COZART EIA OPIATES ORAL FLUID KITK020920COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONEK011131METHADONE MICROPLATE EIA URINE APPLICATION

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 DXK181499DRI Cocaine Metabolite AssayMicrogenics CorporationK170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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