Name: Predicase
Price: 199 USD

K-number	K010030
Device name	LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR
Applicant	Synergent Biochem Inc.-Clinical Controls Div.
Product code	JIX
Device class	Class II
Decision date	Feb 14, 2001
Decision	Substantially Equivalent
Regulation	862.1150

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Source

View the full FDA submission: accessdata.fda.gov

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LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR

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