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)

THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY

K-Number: K101744 · 2011-04-08

ApplicantMicrogenics Corp.
Decision Date2011-04-08
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT 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 2011-04-08 under 510(k) number K101744. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY?

THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY is a medical device that received FDA 510(k) clearance on 2011-04-08. The listed applicant is Microgenics Corp.. The 510(k) number is K101744.

When did THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY receive FDA 510(k) clearance?

THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY received FDA 510(k) clearance on 2011-04-08, under 510(k) number K101744.

Who is the listed applicant for THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT 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 THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY?

The FDA product code for THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY is LDJ.

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: LDJ)

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.

K232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50Co-Innovation Biotech Co., Ltd.K232604LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)Hangzhou Laihe Biotech Co., Ltd.K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTHealgen Scientific,, LLCK192515BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20Shenzhen Bioeasy Biotechnology Co., Ltd.K153741CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana TestHangzhou Clongene Biotech Co., Ltd.K130213QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICELumiquick Diagnostics, 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.

↑