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)

TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002

K-Number: K014247 · 2002-06-03

ApplicantBiosite Incorporated
Decision Date2002-06-03
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 is the device name listed in this FDA 510(k) record. The listed applicant is Biosite Incorporated. It received FDA 510(k) clearance on 2002-06-03 under 510(k) number K014247. 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 TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002?

TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 is a medical device that received FDA 510(k) clearance on 2002-06-03. The listed applicant is Biosite Incorporated. The 510(k) number is K014247.

When did TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 receive FDA 510(k) clearance?

TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 received FDA 510(k) clearance on 2002-06-03, under 510(k) number K014247.

Who is the listed applicant for TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002?

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

What is the FDA product code for TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002?

The FDA product code for TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 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 Biosite Incorporated 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.

K092987INRATIO/INRATIO2 TEST STRIPSK092048ONE STEP EDDP (METHADONE METABOLITE) TEST STRIPK093032TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SETK080269TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELSK072892TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5K062840TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS

View all 45 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.

↑