Name: Predicase
Price: 199 USD

K-number	K003851
Device name	BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119
Applicant	Biocheck, Inc.
Product code	DCK
Device class	Class II
Decision date	Jul 20, 2001
Decision	Substantially Equivalent
Regulation	866.5270

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Source

View the full FDA submission: accessdata.fda.gov

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BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119

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