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)

DRUGS OF ABUSE MULTI-TEST STRIP

K-Number: K011952 · 2001-10-25

ApplicantMicrodiagnostics, Inc.
Decision Date2001-10-25
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRUGS OF ABUSE MULTI-TEST STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Microdiagnostics, Inc.. It received FDA 510(k) clearance on 2001-10-25 under 510(k) number K011952. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRUGS OF ABUSE MULTI-TEST STRIP?

DRUGS OF ABUSE MULTI-TEST STRIP is a medical device that received FDA 510(k) clearance on 2001-10-25. The listed applicant is Microdiagnostics, Inc.. The 510(k) number is K011952.

When did DRUGS OF ABUSE MULTI-TEST STRIP receive FDA 510(k) clearance?

DRUGS OF ABUSE MULTI-TEST STRIP received FDA 510(k) clearance on 2001-10-25, under 510(k) number K011952.

Who is the listed applicant for DRUGS OF ABUSE MULTI-TEST STRIP?

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

What is the FDA product code for DRUGS OF ABUSE MULTI-TEST STRIP?

The FDA product code for DRUGS OF ABUSE MULTI-TEST STRIP is DKZ.

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 Microdiagnostics, 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.

K991516MICRO-STRIP FOR MARIJUANA METABOLITESK991505MICRO-STRIP FOR PHENCYCLIDINE METABOLITESK981388MICRO-STRIP FOR COCAINE METABOLITESK974611MICRO-STRIP FOR AMPHETAMINE METABOLITESK973761MICRO-STRIP FOR OPIATE METABOLITESK932304MICRO EIA FOR AMPHETAMINE METABOLITES

View all 10 devices →

Related Devices (Code: DKZ)

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.

K240670DRI Ecstasy Plus AssayMicrogenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas MedicalK182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.

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.

↑