FDA 510(k)

AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA

K-Number: K100108 · 2010-04-14

Decision Date2010-04-14

Product CodeNGL

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA 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 2010-04-14 under 510(k) number K100108. 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 TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA?

AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA is a medical device that received FDA 510(k) clearance on 2010-04-14. The listed applicant is Amedica Biotech, Inc.. The 510(k) number is K100108.

When did AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA receive FDA 510(k) clearance?

AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA received FDA 510(k) clearance on 2010-04-14, under 510(k) number K100108.

Who is the listed applicant for AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA?

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 TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA?

The FDA product code for AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA is NGL.

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Other records listing Amedica Biotech, Inc. as applicant

K082898AMEDICA DRUG SCREEN TEST CUP 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)

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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.