Name: Predicase
Price: 199 USD

K-number	K142373
Device name	Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst
Applicant	Beckman Coulter, Inc.
Product code	MRG
Device class	Class II
Decision date	Dec 22, 2014
Decision	Substantially Equivalent
Regulation	862.1825

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Source

View the full FDA submission: accessdata.fda.gov

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Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst

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