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FDA 510(k)

AMEDICA DRUG SCREEN THC TEST

K-Number: K022955 · 2002-11-06

ApplicantAmedica Biotech, Inc.
Decision Date2002-11-06
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMEDICA DRUG SCREEN THC TEST is the device name listed in this FDA 510(k) record. The listed applicant is Amedica Biotech, Inc.. It received FDA 510(k) clearance on 2002-11-06 under 510(k) number K022955. 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 AMEDICA DRUG SCREEN THC TEST?

AMEDICA DRUG SCREEN THC TEST is a medical device that received FDA 510(k) clearance on 2002-11-06. The listed applicant is Amedica Biotech, Inc.. The 510(k) number is K022955.

When did AMEDICA DRUG SCREEN THC TEST receive FDA 510(k) clearance?

AMEDICA DRUG SCREEN THC TEST received FDA 510(k) clearance on 2002-11-06, under 510(k) number K022955.

Who is the listed applicant for AMEDICA DRUG SCREEN THC TEST?

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

What is the FDA product code for AMEDICA DRUG SCREEN THC TEST?

The FDA product code for AMEDICA DRUG SCREEN THC TEST is LDJ.

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Other records listing Amedica Biotech, 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.

K100108AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCAK082898AMEDICA DRUG SCREEN TEST CUPK080872AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZK063379AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220K061556AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020K040464AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO 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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