K-number	DEN990008
Device name	WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000
Applicant	Wallac, Inc.
Product code	NAK
Device class	Class II
Decision date	Feb 15, 2000
Decision	Not Substantially Equivalent
Regulation	862.1118

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WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000

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