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FDA 510(k)

AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST

K-Number: K040464 · 2004-05-17

ApplicantAmedica Biotech, Inc.
Decision Date2004-05-17
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO 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 2004-05-17 under 510(k) number K040464. 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, OP1300, PPX, OXY, BAR/BZO TEST?

AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST is a medical device that received FDA 510(k) clearance on 2004-05-17. The listed applicant is Amedica Biotech, Inc.. The 510(k) number is K040464.

When did AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST receive FDA 510(k) clearance?

AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST received FDA 510(k) clearance on 2004-05-17, under 510(k) number K040464.

Who is the listed applicant for AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO 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/COC, OP1300, PPX, OXY, BAR/BZO TEST?

The FDA product code for AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO 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,C1020K031497AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA 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.

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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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