K-number	K003664
Device name	DELFIA NEONATAL IRT KIT, MODEL A005-110
Applicant	Wallac OY
Product code	CGZ
Device class	Class II
Decision date	Feb 14, 2001
Decision	Substantially Equivalent
Regulation	862.1170

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View the full FDA submission: accessdata.fda.gov

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DELFIA NEONATAL IRT KIT, MODEL A005-110

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