Name: Predicase
Price: 199 USD

K-number	K133512
Device name	LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)
Applicant	Siemens Healthcare Diagnostics
Product code	CDD
Device class	Class II
Decision date	Jan 2, 2014
Decision	Substantially Equivalent
Regulation	862.1810

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Source

View the full FDA submission: accessdata.fda.gov

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LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)

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