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FDA 510(k)

ADVANTAGE MARIJUANA (THC) HOME DRUG TEST

K-Number: K010921 · 2001-06-25

ApplicantAdvantage Diagnostics Corp.
Decision Date2001-06-25
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ADVANTAGE MARIJUANA (THC) HOME DRUG TEST is the device name listed in this FDA 510(k) record. The listed applicant is Advantage Diagnostics Corp.. It received FDA 510(k) clearance on 2001-06-25 under 510(k) number K010921. 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 ADVANTAGE MARIJUANA (THC) HOME DRUG TEST?

ADVANTAGE MARIJUANA (THC) HOME DRUG TEST is a medical device that received FDA 510(k) clearance on 2001-06-25. The listed applicant is Advantage Diagnostics Corp.. The 510(k) number is K010921.

When did ADVANTAGE MARIJUANA (THC) HOME DRUG TEST receive FDA 510(k) clearance?

ADVANTAGE MARIJUANA (THC) HOME DRUG TEST received FDA 510(k) clearance on 2001-06-25, under 510(k) number K010921.

Who is the listed applicant for ADVANTAGE MARIJUANA (THC) HOME DRUG TEST?

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

What is the FDA product code for ADVANTAGE MARIJUANA (THC) HOME DRUG TEST?

The FDA product code for ADVANTAGE MARIJUANA (THC) HOME DRUG TEST 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.

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Other records listing Advantage 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.

K023712ADVANTAGE MULTIPLE DRUGS OF ABUSE TESTK013778PEACE OF MIND HOME DRUG TESTK011962ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TESTK003708ADVANTAGE THC/COCAINE TESTK001567ADVANTAGE THC TESTK994227ADVANTAGE HCG TEST (URINE/SERUM)

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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.

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