Name: Predicase
Price: 199 USD

K-number	K100375
Device name	DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	NIG
Device class	Class II
Decision date	Apr 6, 2011
Decision	Substantially Equivalent
Regulation	866.6010

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Source

View the full FDA submission: accessdata.fda.gov

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DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604

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