Name: Predicase
Price: 199 USD

K-number	K153365
Device name	ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	JIX
Device class	Class II
Decision date	Dec 18, 2015
Decision	Substantially Equivalent
Regulation	862.1150

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Source

View the full FDA submission: accessdata.fda.gov

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ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator

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