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FDA 510(k)

QUIKSTRIP ONESTEP MARIJUANA (THC) TEST

K-Number: K963654 · 1997-02-28

ApplicantSyntron Bioresearch, Inc.
Decision Date1997-02-28
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUIKSTRIP ONESTEP MARIJUANA (THC) TEST is the device name listed in this FDA 510(k) record. The listed applicant is Syntron Bioresearch, Inc.. It received FDA 510(k) clearance on 1997-02-28 under 510(k) number K963654. 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 QUIKSTRIP ONESTEP MARIJUANA (THC) TEST?

QUIKSTRIP ONESTEP MARIJUANA (THC) TEST is a medical device that received FDA 510(k) clearance on 1997-02-28. The listed applicant is Syntron Bioresearch, Inc.. The 510(k) number is K963654.

When did QUIKSTRIP ONESTEP MARIJUANA (THC) TEST receive FDA 510(k) clearance?

QUIKSTRIP ONESTEP MARIJUANA (THC) TEST received FDA 510(k) clearance on 1997-02-28, under 510(k) number K963654.

Who is the listed applicant for QUIKSTRIP ONESTEP MARIJUANA (THC) TEST?

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

What is the FDA product code for QUIKSTRIP ONESTEP MARIJUANA (THC) TEST?

The FDA product code for QUIKSTRIP ONESTEP MARIJUANA (THC) TEST is LDJ.

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Other records listing Syntron Bioresearch, 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.

K993491QUICKPAC II ONE STEP OPIATES TESTK993490QUICKSTRIP ONE STEP OPIATES TESTK992990QUICKPAC II ONE STEP COCAINE TESTK992748DRUGCHECK X MULTIDRUG SCREENING DEVICEK992207QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEMK990325QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE

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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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