K-number	K993536
Device name	BIO-RAD CODA NEONATAL GALT ASSAY
Applicant	Bio-Rad
Product code	KQP
Device class	Class II
Decision date	Nov 4, 1999
Decision	Substantially Equivalent
Regulation	862.1315

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View the full FDA submission: accessdata.fda.gov

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BIO-RAD CODA NEONATAL GALT ASSAY

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