Name: Predicase
Price: 199 USD

K-number	K230956
Device name	BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System
Applicant	Bd Integrated Diagnostic Solutions /
Product code	QOF
Device class	Class II
Decision date	Jul 31, 2023
Decision	Substantially Equivalent
Regulation	866.3981

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Source

View the full FDA submission: accessdata.fda.gov

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BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System

Everything you need for a 510(k) submission. Nothing you don't.

BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System