Name: Predicase
Price: 199 USD

K-number	K063150
Device name	COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
Applicant	Thermo Electron OY
Product code	CZW
Device class	Class II
Decision date	Mar 19, 2007
Decision	Substantially Equivalent
Regulation	866.5240

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Source

View the full FDA submission: accessdata.fda.gov

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COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL

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