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)

CEDIA DAU AMPHETAMINES/ECSTASY ASSAY

K-Number: K010496 · 2001-05-29

ApplicantMicrogenics Corp.
Decision Date2001-05-29
Product CodeLAF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA DAU AMPHETAMINES/ECSTASY ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 2001-05-29 under 510(k) number K010496. 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 CEDIA DAU AMPHETAMINES/ECSTASY ASSAY?

CEDIA DAU AMPHETAMINES/ECSTASY ASSAY is a medical device that received FDA 510(k) clearance on 2001-05-29. The listed applicant is Microgenics Corp.. The 510(k) number is K010496.

When did CEDIA DAU AMPHETAMINES/ECSTASY ASSAY receive FDA 510(k) clearance?

CEDIA DAU AMPHETAMINES/ECSTASY ASSAY received FDA 510(k) clearance on 2001-05-29, under 510(k) number K010496.

Who is the listed applicant for CEDIA DAU AMPHETAMINES/ECSTASY ASSAY?

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

What is the FDA product code for CEDIA DAU AMPHETAMINES/ECSTASY ASSAY?

The FDA product code for CEDIA DAU AMPHETAMINES/ECSTASY ASSAY 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 Microgenics 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.

K122766THERMO SCIENTIFIC QMS EVEROLIMUS ASSAYK123343THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSK123271ABBOTT PHENOBARBITAL ASSAYK110616THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PROK101754THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAYK101746THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY

View all 106 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.

↑