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)

ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686

K-Number: K000096 · 2000-04-26

ApplicantRoche Diagnostics Corp.
Decision Date2000-04-26
Product CodeLAF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2000-04-26 under 510(k) number K000096. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686?

ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 is a medical device that received FDA 510(k) clearance on 2000-04-26. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K000096.

When did ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 receive FDA 510(k) clearance?

ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 received FDA 510(k) clearance on 2000-04-26, under 510(k) number K000096.

Who is the listed applicant for ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686?

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

What is the FDA product code for ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686?

The FDA product code for ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 is LAF.

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 Roche Diagnostics Corp. 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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

View all 263 devices →

Related Devices (Code: LAF)

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.

K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis CorporationK210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics CorporationK201442Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus AnalyzersDiatron GroupK170222Rapid Tox Cup IIAmerican Bio Medica Corp.K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis CorporationK111927PSYCHEMEDICS METHAMPHETAMINE EIAPsychemedics Corp.

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.

↑