FDA 510(k)

AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020

K-Number: K061556 · 2006-07-21

Decision Date2006-07-21

Product CodeLDJ

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 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 2006-07-21 under 510(k) number K061556. 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, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020?

AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 is a medical device that received FDA 510(k) clearance on 2006-07-21. The listed applicant is Amedica Biotech, Inc.. The 510(k) number is K061556.

When did AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 receive FDA 510(k) clearance?

AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 received FDA 510(k) clearance on 2006-07-21, under 510(k) number K061556.

Who is the listed applicant for AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020?

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, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020?

The FDA product code for AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 is LDJ.

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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 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 K040464AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST K031497AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST

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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.