Name: Predicase
Price: 199 USD

K-number	K201017
Device name	BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit
Applicant	Geneohm Sciences Canada, Inc. (Bd Life Sciences)
Product code	PQA
Device class	Class II
Decision date	Oct 18, 2021
Decision	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 System, BD Molecular Swab Collection Kit

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