K-number	K082210
Device name	TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
Applicant	Genzyme Diagnostics P.E.I., Inc.
Product code	CIG
Device class	Class II
Decision date	Dec 16, 2008
Decision	Substantially Equivalent
Regulation	862.1110

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TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30

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