Name: Predicase
Price: 199 USD

K-number	K071649
Device name	NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B
Applicant	Wallac OY
Product code	JIA
Device class	Class I
Decision date	Aug 7, 2008
Decision	Substantially Equivalent
Regulation	862.1310

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Source

View the full FDA submission: accessdata.fda.gov

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NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B

Everything you need for a 510(k) submission. Nothing you don't.