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)

MICRO-STRIP FOR COCAINE METABOLITES

K-Number: K981388 · 1998-05-29

ApplicantMicrodiagnostics, Inc.
Decision Date1998-05-29
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MICRO-STRIP FOR COCAINE METABOLITES is the device name listed in this FDA 510(k) record. The listed applicant is Microdiagnostics, Inc.. It received FDA 510(k) clearance on 1998-05-29 under 510(k) number K981388. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-STRIP FOR COCAINE METABOLITES?

MICRO-STRIP FOR COCAINE METABOLITES is a medical device that received FDA 510(k) clearance on 1998-05-29. The listed applicant is Microdiagnostics, Inc.. The 510(k) number is K981388.

When did MICRO-STRIP FOR COCAINE METABOLITES receive FDA 510(k) clearance?

MICRO-STRIP FOR COCAINE METABOLITES received FDA 510(k) clearance on 1998-05-29, under 510(k) number K981388.

Who is the listed applicant for MICRO-STRIP FOR COCAINE METABOLITES?

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 MICRO-STRIP FOR COCAINE METABOLITES?

The FDA product code for MICRO-STRIP FOR COCAINE METABOLITES is DIO.

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.

K011952DRUGS OF ABUSE MULTI-TEST STRIPK991516MICRO-STRIP FOR MARIJUANA METABOLITESK991505MICRO-STRIP FOR PHENCYCLIDINE METABOLITESK974611MICRO-STRIP FOR AMPHETAMINE METABOLITESK973761MICRO-STRIP FOR OPIATE METABOLITESK932304MICRO EIA FOR AMPHETAMINE METABOLITES

View all 10 devices →

Related Devices (Code: DIO)

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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.K211973DRI Cocaine Metabolite AssayMicrogenics CorporationK191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DXK181499DRI Cocaine Metabolite AssayMicrogenics CorporationK170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries Corporation

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.

↑