FDA 510(k)

AMEDICA DRUG SCREEN TEST CUP

K-Number: K082898 · 2008-12-19

Decision Date2008-12-19

Product CodeNGL

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

AMEDICA DRUG SCREEN TEST CUP 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 2008-12-19 under 510(k) number K082898. The device is classified under product code NGL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMEDICA DRUG SCREEN TEST CUP?

AMEDICA DRUG SCREEN TEST CUP is a medical device that received FDA 510(k) clearance on 2008-12-19. The listed applicant is Amedica Biotech, Inc.. The 510(k) number is K082898.

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

AMEDICA DRUG SCREEN TEST CUP received FDA 510(k) clearance on 2008-12-19, under 510(k) number K082898.

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

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 TEST CUP?

The FDA product code for AMEDICA DRUG SCREEN TEST CUP is NGL.

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Other records listing Amedica Biotech, Inc. as applicant

K100108AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA K080872AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ K063379AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220 K061556AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 K040464AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST K031497AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST

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Related Devices (Code: NGL)

K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardHealgen Scientific,, LLC K250803Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupAnhui Deepblue Medical Technological Co., Ltd.K250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProGuangzhou Decheng Biotechnology Co., Ltd.K242428Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup PlusGuangzhou Decheng Biotechnology Co., Ltd.K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test CupHealgen Scientific,, LLC K243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home TestEterbio, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.