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)

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)

K-Number: K122759 · 2012-12-05

ApplicantOmega Laboratories, Inc.
Decision Date2012-12-05
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) is the device name listed in this FDA 510(k) record. The listed applicant is Omega Laboratories, Inc.. It received FDA 510(k) clearance on 2012-12-05 under 510(k) number K122759. 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 OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)?

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) is a medical device that received FDA 510(k) clearance on 2012-12-05. The listed applicant is Omega Laboratories, Inc.. The 510(k) number is K122759.

When did OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) receive FDA 510(k) clearance?

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) received FDA 510(k) clearance on 2012-12-05, under 510(k) number K122759.

Who is the listed applicant for OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)?

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

What is the FDA product code for OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)?

The FDA product code for OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) 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 Omega Laboratories, 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.

K131128OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITESK131181OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINEK112808OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITESK103161OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATESK101973OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)K101059OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE

View all 7 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.

↑