Name: Predicase
Price: 199 USD

K-number	K213280
Device name	BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
Applicant	Bd Kiestra B.V.
Product code	QQY
Device class	Class II
Decision date	May 4, 2023
Decision	Substantially Equivalent
Regulation	866.2190

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Source

View the full FDA submission: accessdata.fda.gov

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BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App

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