Name: Predicase
Price: 199 USD

K-number	K142878
Device name	IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	JJX
Device class	Class I
Decision date	Oct 30, 2014
Decision	Substantially Equivalent
Regulation	862.1660

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Source

View the full FDA submission: accessdata.fda.gov

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IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material

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