Name: Predicase
Price: 199 USD

K-number	K033706
Device name	POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS
Applicant	Polymedco, Inc.
Product code	LPS
Device class	Class II
Decision date	Feb 4, 2004
Decision	Substantially Equivalent
Regulation	862.1377

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Source

View the full FDA submission: accessdata.fda.gov

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POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS

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