K103227

Substantially Equivalent

ORATECT ORAL FLUID DRUG SCREEN DEVICES

Applicant: Branan Medical Corporation
Product code: DIO
Advisory panel: Clinical Toxicology
Date received: 2010-11-01
Decision date: 2012-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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