THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY— 510(k) K101742

Name: FDA 510(k) clearance K101742
Creator: U.S. Food and Drug Administration
Published: 2011-04-08

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K101742 for THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY, Substantially Equivalent on 2011-04-08. Applicant: Microgenics Corp.. Device class: 2.

Clearance details

Applicant: Microgenics Corp.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2010-06-22
Decision date: 2011-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont Blvd., 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 Microgenics Corp.

view all

K122766 — THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY2013-08-20
K123343 — THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS2013-07-11
K123271 — ABBOTT PHENOBARBITAL ASSAY2013-04-26
K110616 — THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO2011-06-29
K101744 — THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY2011-04-08

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