Name: Predicase
Price: 199 USD

K-number	K150270
Device name	ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set
Applicant	Tosoh Bioscience, Inc.
Product code	MRG
Device class	Class II
Decision date	Oct 26, 2015
Decision	Substantially Equivalent
Regulation	862.1825

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Source

View the full FDA submission: accessdata.fda.gov

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ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set

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