Name: Predicase
Price: 199 USD

K-number	K060133
Device name	ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET
Applicant	Inverness Medical Innovations, Inc.
Product code	JJX
Device class	Class I
Decision date	Feb 16, 2006
Decision	Substantially Equivalent
Regulation	862.1660

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Source

View the full FDA submission: accessdata.fda.gov

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ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET

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