Name: Predicase
Price: 199 USD

K-number	DEN160001
Device name	BD MAX Vaginal Panel, BD MAX Instrument
Applicant	Geneohm Sciences Canada, Inc. (Bd Diagnostics)
Product code	PQA
Device class	Class II
Decision date	Oct 28, 2016
Decision	Not Substantially Equivalent
Regulation	866.3975

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Source

View the full FDA submission: accessdata.fda.gov

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BD MAX Vaginal Panel, BD MAX Instrument

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