Cleared Traditional

K103227 - ORATECT ORAL FLUID DRUG SCREEN DEVICES
(FDA 510(k) Clearance)

K103227 · Branan Medical Corporation · Toxicology

Apr 2012

Decision

527d

Days

Class 2

Risk

K103227 is an FDA 510(k) clearance for the ORATECT ORAL FLUID DRUG SCREEN DEVICES, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Branan Medical Corporation (Irvine, US). The FDA issued a Cleared decision on April 11, 2012, 527 days after receiving the submission on November 1, 2010. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number	K103227 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 2010
Decision Date	April 11, 2012
Days to Decision	527 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF