BD VIPER LT SYSTEM

Real Time Nucleic Acid Amplification System

The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Viper Lt System.

Device ID	K140447
510k Number	K140447
Device Name:	BD VIPER LT SYSTEM
Classification	Real Time Nucleic Acid Amplification System
Applicant	Becton, Dickinson And Company 7 LOVETON CIRCLE Sparks, MD 21152
Contact	Sherma Winston
Correspondent	Sherma Winston Becton, Dickinson And Company 7 LOVETON CIRCLE Sparks, MD 21152
Product Code	OOI
CFR Regulation Number	862.2570 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2014-02-21
Decision Date	2014-05-20
Summary:	summary