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FDA 510(k)

AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ

K-Number: K080872 · 2008-08-19

ApplicantAmedica Biotech, Inc.
Decision Date2008-08-19
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ 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 2008-08-19 under 510(k) number K080872. 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 AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ?

AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ is a medical device that received FDA 510(k) clearance on 2008-08-19. The listed applicant is Amedica Biotech, Inc.. The 510(k) number is K080872.

When did AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ receive FDA 510(k) clearance?

AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ received FDA 510(k) clearance on 2008-08-19, under 510(k) number K080872.

Who is the listed applicant for AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ?

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 AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ?

The FDA product code for AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ 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 CUPK063379AMEDICA 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 TESTK031497AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST

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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.

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