Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

METHADONE ENZYME IMMUNOASSAY

K-Number: K023317 · 2002-12-12

ApplicantLin-Zhi International, Inc.
Decision Date2002-12-12
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

METHADONE ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Lin-Zhi International, Inc.. It received FDA 510(k) clearance on 2002-12-12 under 510(k) number K023317. 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 ENZYME IMMUNOASSAY?

METHADONE ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2002-12-12. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K023317.

When did METHADONE ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

METHADONE ENZYME IMMUNOASSAY received FDA 510(k) clearance on 2002-12-12, under 510(k) number K023317.

Who is the listed applicant for METHADONE ENZYME IMMUNOASSAY?

The FDA 510(k) record lists Lin-Zhi International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METHADONE ENZYME IMMUNOASSAY?

The FDA product code for METHADONE ENZYME IMMUNOASSAY 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 Lin-Zhi International, Inc. 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.

K253082LZI Buprenorphine II Enzyme ImmunoassayK251634LZI Fentanyl III Enzyme ImmunoassayK202007LZI Oxycodone III Enzyme ImmunoassayK201938LZI Fentanyl II Enzyme ImmunoassayK201223LZI Tramadol Enzyme ImmunoassayK192299LZI Cotinine II Enzyme Immunoassay

View all 43 devices →

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

View on FDA Database →

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

↑