Amedica Drug Screen Thc, Coc, Opi, Amp, Met, Pcp, Mdma, Bar, Bzo, ; Model C1010, C1015, C1020

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

510(k) Number

K061556 ↗

FDA Product Code

LDJ

Models / Variants

Amedica Drug Screen Thc, Coc, Opi, Amp, Met, Pcp, Mdma, Bar, Bzo,

Model C1010, C1015, C1020

Device Class

Class II

Regulation

21 CFR Part 862.3870

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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