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FDA 510(k)

COZART EIA COTININE URINE KIT

K-Number: K021944 · 2003-05-14

ApplicantCozart Bioscience , Ltd.
Decision Date2003-05-14
Product CodeMKU
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COZART EIA COTININE URINE 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 2003-05-14 under 510(k) number K021944. The device is classified under product code MKU. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COZART EIA COTININE URINE KIT?

COZART EIA COTININE URINE KIT is a medical device that received FDA 510(k) clearance on 2003-05-14. The listed applicant is Cozart Bioscience , Ltd.. The 510(k) number is K021944.

When did COZART EIA COTININE URINE KIT receive FDA 510(k) clearance?

COZART EIA COTININE URINE KIT received FDA 510(k) clearance on 2003-05-14, under 510(k) number K021944.

Who is the listed applicant for COZART EIA COTININE URINE 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 COTININE URINE KIT?

The FDA product code for COZART EIA COTININE URINE KIT is MKU.

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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 KITK030234COZART EIA COCAINE ORAL FLIUD KITK024339COZART EIA OPIATES ORAL FLUID KITK020920COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONEK011131METHADONE MICROPLATE EIA URINE APPLICATION

Related Devices (Code: MKU)

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.

K192517Psychemedics Microplate EIA for Cotinine in HairPsychemedics CorporationK192299LZI Cotinine II Enzyme ImmunoassayLin-Zhi International, Inc.K062565STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINEPrinceton BioMeditech Corp.K974534MICRO-PLATE COTININE EIAOraSure Technologies, Inc.K974234MICRO-PLATE COTININE EIAOraSure Technologies, Inc.K972481AUTO-LYTE COTININE EIAOraSure Technologies, 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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