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)

MICROLINE SCREEN FOR BENZODIAZEPINE

K-Number: K945829 · 1995-01-25

ApplicantDrug Screening Systems, Inc.
Decision Date1995-01-25
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MICROLINE SCREEN FOR BENZODIAZEPINE is the device name listed in this FDA 510(k) record. The listed applicant is Drug Screening Systems, Inc.. It received FDA 510(k) clearance on 1995-01-25 under 510(k) number K945829. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROLINE SCREEN FOR BENZODIAZEPINE?

MICROLINE SCREEN FOR BENZODIAZEPINE is a medical device that received FDA 510(k) clearance on 1995-01-25. The listed applicant is Drug Screening Systems, Inc.. The 510(k) number is K945829.

When did MICROLINE SCREEN FOR BENZODIAZEPINE receive FDA 510(k) clearance?

MICROLINE SCREEN FOR BENZODIAZEPINE received FDA 510(k) clearance on 1995-01-25, under 510(k) number K945829.

Who is the listed applicant for MICROLINE SCREEN FOR BENZODIAZEPINE?

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

What is the FDA product code for MICROLINE SCREEN FOR BENZODIAZEPINE?

The FDA product code for MICROLINE SCREEN FOR BENZODIAZEPINE is JXM.

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 Drug Screening Systems, 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.

K935052MICROLINE SCREEN FOR AMPHETAMINEK933480MICROLINE SCREEN FOR BARBITURATESK921651MICROLINE SCREEN FOR PHENCYCLIDINEK914915MICROLINE SCREEN FOR CANNABINOIDK911652MIRCOLINE SCREEN FOR COCAINEK910525MICROLINE SCREEN FOR METHAMPHETAMINE

View all 8 devices →

Related Devices (Code: JXM)

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.

K243498Alinity c Benzodiazepines Reagent KitMicrogenics CorporationK221765ONLINE DAT Benzodiazepines IIRoche DiagnosticsK190968CEDIA Benzodiazepine AssayMicrogenics CorporationK173963DRI Benzodiazepine AssayMicrogenics CorporationK163590Psychemedics Microplate EIA for Benzodiazepines in HairPsychemedics CorporationK163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC

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.

↑