ORATECT ORAL FLUID DRUG SCREEN DEVICES

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

The following data is part of a premarket notification filed by Branan Medical Corporation with the FDA for Oratect Oral Fluid Drug Screen Devices.

Device ID	K103227
510k Number	K103227
Device Name:	ORATECT ORAL FLUID DRUG SCREEN DEVICES
Classification	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant	BRANAN MEDICAL CORPORATION 140 TECHNOLOGY DRIVE SUITE 400 Irvine, CA 92618
Contact	Huiying Wang
Correspondent	Huiying Wang BRANAN MEDICAL CORPORATION 140 TECHNOLOGY DRIVE SUITE 400 Irvine, CA 92618
Product Code	DIO
Subsequent Product Code	DIF
Subsequent Product Code	DJC
Subsequent Product Code	DJG
Subsequent Product Code	DKZ
Subsequent Product Code	LCM
Subsequent Product Code	LDJ
CFR Regulation Number	862.3250 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2010-11-01
Decision Date	2012-04-11
Summary:	summary