Name: Predicase
Price: 199 USD

K-number	K153165
Device name	NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit
Applicant	Astute Medical, Inc.
Product code	PIG
Device class	Class II
Decision date	Jun 1, 2016
Decision	Substantially Equivalent
Regulation	862.1220

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Source

View the full FDA submission: accessdata.fda.gov

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NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit

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