Name: Predicase
Price: 199 USD

K-number	K161721
Device name	Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
Applicant	Diazyme Laboratories
Product code	CDD
Device class	Class II
Decision date	Sep 20, 2016
Decision	Substantially Equivalent
Regulation	862.1810

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Source

View the full FDA submission: accessdata.fda.gov

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Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set

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