Name: Predicase
Price: 199 USD

K-number	K160462
Device name	FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
Applicant	Biofire Diagnostics, LLC
Product code	PLO
Device class	Class II
Decision date	Mar 17, 2016
Decision	Substantially Equivalent
Regulation	866.3970

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Source

View the full FDA submission: accessdata.fda.gov

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FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch

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