K-number	K011579
Device name	LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
Applicant	Bio-Rad
Product code	JJY
Device class	Class I
Decision date	Jun 26, 2001
Decision	Substantially Equivalent
Regulation	862.1660

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LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580

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