K-number	K895118
Device name	SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407
Applicant	Em Diagnostic Systems, Inc.
Product code	CIG
Device class	Class II
Decision date	Oct 17, 1989
Decision	Substantially Equivalent
Regulation	862.1110

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SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407

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