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FDA 510(k)

ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)

K-Number: K951853 · 1996-08-20

ApplicantTcpi, Inc.
Decision Date1996-08-20
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) is the device name listed in this FDA 510(k) record. The listed applicant is Tcpi, Inc.. It received FDA 510(k) clearance on 1996-08-20 under 510(k) number K951853. 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 ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)?

ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) is a medical device that received FDA 510(k) clearance on 1996-08-20. The listed applicant is Tcpi, Inc.. The 510(k) number is K951853.

When did ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) receive FDA 510(k) clearance?

ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) received FDA 510(k) clearance on 1996-08-20, under 510(k) number K951853.

Who is the listed applicant for ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)?

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

What is the FDA product code for ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)?

The FDA product code for ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) is LDJ.

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Other records listing Tcpi, 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.

K981363ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TESTK972960HEALTH CHECK URI-TEST PROTEIN IN URINEK981197ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TESTK980776ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TESTK954968HEALTH CHECK URI-TEST GLUCOSE IN URINE TESTK954685URITEST - NITRITE IN URINE TEST

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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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