AMEDICA DRUG SCREEN COCAINE TEST— 510(k) K022954

Clearance details

Applicant

Amedica Biotech, Inc.

Product code

Code DIO

Device class

Class 2

Regulation

21 CFR 862.3250

Advisory panel

Clinical Toxicology

Date received

2002-09-05

Decision date

2002-11-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hayward, CA, US

• K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System2022-01-27
• K211973 — DRI Cocaine Metabolite Assay2021-09-24
• K191638 — Pointe Scientific Cocaine Metabolite Enzyme Immunoassay2020-03-12
• K181499 — DRI Cocaine Metabolite Assay2018-07-06
• K170293 — Emit II Plus Cocaine Metabolite Assay2017-10-25

• K100108 — AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA2010-04-14
• K082898 — AMEDICA DRUG SCREEN TEST CUP2008-12-19
• K080872 — AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ2008-08-19
• K063379 — AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C12202006-12-11
• K061556 — AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C10202006-07-21