Name: Predicase
Price: 199 USD

K-number	K093623
Device name	GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO
Applicant	Instrumentation Laboratory CO
Product code	CIG
Device class	Class II
Decision date	Jun 18, 2010
Decision	Substantially Equivalent
Regulation	862.1110

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Source

View the full FDA submission: accessdata.fda.gov

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GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO

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