Name: Predicase
Price: 199 USD

K-number	K193081
Device name	Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit
Applicant	Rheonix, Inc.
Product code	QEP
Device class	Class II
Decision date	Dec 17, 2021
Decision	Substantially Equivalent
Regulation	866.3393

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Source

View the full FDA submission: accessdata.fda.gov

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Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit

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