K-number	K990644
Device name	QUANTASE TOTAL GALACTOSE SCREENING ASSAY
Applicant	Quantase , Ltd.
Product code	JIA
Device class	Class I
Decision date	Jun 21, 1999
Decision	Substantially Equivalent
Regulation	862.1310

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View the full FDA submission: accessdata.fda.gov

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QUANTASE TOTAL GALACTOSE SCREENING ASSAY

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