Amedica Drug Screen Thc, Coc, Opi, Amp, Met, Pcp, Mdma, Bar, Bzo, M, Models C1210, C1220

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K063379 ↗

FDA Product Code

DKZ

Device Class

Class II

Regulation

21 CFR Part 862.3100

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Amedica Drug Screen Test Cup

  Class II

  FDA 510(k) K082898 Active Cleared 19 Dec 2008

• Amedica Drug Screen Phencyclidine Test

  Unclassified

  FDA 510(k) K023109 Active Cleared 16 Dec 2002

• Amedica Drug Screen Mdma-Bar-Bzo-Mtd-Tca Test

  Class II

  FDA 510(k) K031497 Active Cleared 17 Oct 2003

• Amedica Drug Test Thc, Coc, Opi, Amp, Met, Pcp, Bar, Bzo, Mdma, Oxy, Tca

  Class II

  FDA 510(k) K100108 Active Cleared 14 Apr 2010

• Amedica Drug Screen Cocaine Test

  Class II

  FDA 510(k) K022954 Active Cleared 6 Nov 2002

• Amedica Drug Screen Methaphetamine Test

  Class II

  FDA 510(k) K023101 Active Cleared 16 Dec 2002

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