Name: Predicase
Price: 199 USD

K-number	K160724
Device name	ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	CGS
Device class	Class II
Decision date	Sep 7, 2016
Decision	Substantially Equivalent
Regulation	862.1215

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Source

View the full FDA submission: accessdata.fda.gov

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ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator

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