Name: Predicase
Price: 199 USD

K-number	K162897
Device name	Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser
Applicant	Beckman Coulter
Product code	OYE
Device class	Class II
Decision date	Jun 23, 2017
Decision	Substantially Equivalent
Regulation	864.5220

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Source

View the full FDA submission: accessdata.fda.gov

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Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser

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