RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052— 510(k) K080436

Name: FDA 510(k) clearance K080436
Creator: U.S. Food and Drug Administration
Published: 2009-02-11

Substantially Equivalent

Quantrx Biomedical Corporation

FDA 510(k) clearance K080436 for RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052, Substantially Equivalent on 2009-02-11. Applicant: Quantrx Biomedical Corporation. Device class: 2.

Clearance details

Applicant: Quantrx Biomedical Corporation
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2008-02-19
Decision date: 2009-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DIO

view all

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

More clearances from Quantrx Biomedical Corporation

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.