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FDA 510(k)

COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE

K-Number: K020920 · 2002-11-05

ApplicantCozart Bioscience , Ltd.
Decision Date2002-11-05
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE 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 2002-11-05 under 510(k) number K020920. 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 COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE?

COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE is a medical device that received FDA 510(k) clearance on 2002-11-05. The listed applicant is Cozart Bioscience , Ltd.. The 510(k) number is K020920.

When did COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE receive FDA 510(k) clearance?

COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE received FDA 510(k) clearance on 2002-11-05, under 510(k) number K020920.

Who is the listed applicant for COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE?

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 RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE?

The FDA product code for COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE is DJG.

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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 KITK030234COZART EIA COCAINE ORAL FLIUD KITK024339COZART EIA OPIATES ORAL FLUID KITK011131METHADONE MICROPLATE EIA URINE APPLICATION

Related Devices (Code: DJG)

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.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.

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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