Name: Predicase
Price: 199 USD

K-number	K121399
Device name	LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P
Applicant	Luminex Corp.
Product code	NSU
Device class	Class II
Decision date	Jan 9, 2013
Decision	Substantially Equivalent
Regulation	862.2570

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Source

View the full FDA submission: accessdata.fda.gov

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LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P

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