K-number	K170883
Device name	FilmArray NGDS Warrior Panel
Applicant	Biofire Defense, LLC
Product code	PRD
Device class	Class unclassified
Decision date	Jun 22, 2017
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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FilmArray NGDS Warrior Panel

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