K-number	K003668
Device name	AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
Applicant	Wallac OY
Product code	CGZ
Device class	Class II
Decision date	Feb 12, 2001
Decision	Substantially Equivalent
Regulation	862.1170

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View the full FDA submission: accessdata.fda.gov

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AUTODELFIA NEONATAL IRT KIT, MODEL B005-112

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