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FDA 510(k)

COZART EIA OPIATES ORAL FLUID KIT

K-Number: K024339 · 2003-04-07

ApplicantCozart Bioscience , Ltd.
Decision Date2003-04-07
Product CodeDIG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COZART EIA OPIATES ORAL FLUID 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 2003-04-07 under 510(k) number K024339. The device is classified under product code DIG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COZART EIA OPIATES ORAL FLUID KIT?

COZART EIA OPIATES ORAL FLUID KIT is a medical device that received FDA 510(k) clearance on 2003-04-07. The listed applicant is Cozart Bioscience , Ltd.. The 510(k) number is K024339.

When did COZART EIA OPIATES ORAL FLUID KIT receive FDA 510(k) clearance?

COZART EIA OPIATES ORAL FLUID KIT received FDA 510(k) clearance on 2003-04-07, under 510(k) number K024339.

Who is the listed applicant for COZART EIA OPIATES ORAL FLUID 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 OPIATES ORAL FLUID KIT?

The FDA product code for COZART EIA OPIATES ORAL FLUID KIT is DIG.

Related Clinical Trials

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.

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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 KITK020920COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONEK011131METHADONE MICROPLATE EIA URINE APPLICATION

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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