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FDA 510(k)

AMEDITECH IMMUTEST DRUG SCREEN THC

K-Number: K011813 · 2001-10-22

ApplicantAmeditech, Inc.
Decision Date2001-10-22
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMEDITECH IMMUTEST DRUG SCREEN THC is the device name listed in this FDA 510(k) record. The listed applicant is Ameditech, Inc.. It received FDA 510(k) clearance on 2001-10-22 under 510(k) number K011813. 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 AMEDITECH IMMUTEST DRUG SCREEN THC?

AMEDITECH IMMUTEST DRUG SCREEN THC is a medical device that received FDA 510(k) clearance on 2001-10-22. The listed applicant is Ameditech, Inc.. The 510(k) number is K011813.

When did AMEDITECH IMMUTEST DRUG SCREEN THC receive FDA 510(k) clearance?

AMEDITECH IMMUTEST DRUG SCREEN THC received FDA 510(k) clearance on 2001-10-22, under 510(k) number K011813.

Who is the listed applicant for AMEDITECH IMMUTEST DRUG SCREEN THC?

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

What is the FDA product code for AMEDITECH IMMUTEST DRUG SCREEN THC?

The FDA product code for AMEDITECH IMMUTEST DRUG SCREEN THC is LDJ.

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Other records listing Ameditech, 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.

K113501AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)K113046AMEDITECH IMMUTEST MILTI-DRUG SCREENK063015AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150K053175AMEDITECH DRUGSMARTCUPK050186AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL IIIK042975AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II

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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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