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FDA 510(k)

METHADONE MICROPLATE EIA URINE APPLICATION

K-Number: K011131 · 2001-07-31

ApplicantCozart Bioscience , Ltd.
Decision Date2001-07-31
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

METHADONE MICROPLATE EIA URINE APPLICATION 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 2001-07-31 under 510(k) number K011131. The device is classified under product code DJR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METHADONE MICROPLATE EIA URINE APPLICATION?

METHADONE MICROPLATE EIA URINE APPLICATION is a medical device that received FDA 510(k) clearance on 2001-07-31. The listed applicant is Cozart Bioscience , Ltd.. The 510(k) number is K011131.

When did METHADONE MICROPLATE EIA URINE APPLICATION receive FDA 510(k) clearance?

METHADONE MICROPLATE EIA URINE APPLICATION received FDA 510(k) clearance on 2001-07-31, under 510(k) number K011131.

Who is the listed applicant for METHADONE MICROPLATE EIA URINE APPLICATION?

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 METHADONE MICROPLATE EIA URINE APPLICATION?

The FDA product code for METHADONE MICROPLATE EIA URINE APPLICATION is DJR.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 KITK020920COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE

Related Devices (Code: DJR)

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.

K192433LZI Methadone II Enzyme ImmunoassayLin-Zhi International, Inc.K182779ARK EDDP AssayArk Diagnostics, Inc.K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) CalibratorsLin-Zhi International, Inc.K160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)W.H.P.M., Inc.K131232WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)Guangzhou Wondfo Biotech Co., Ltd.K092272RANDOX METHADONE ASSAYRandox Laboratories, Ltd.

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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