K-number	K983399
Device name	GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY
Applicant	Genzyme Diagnostics
Product code	MHI
Device class	Class II
Decision date	Jan 11, 1999
Decision	Substantially Equivalent
Regulation	866.3220

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View the full FDA submission: accessdata.fda.gov

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GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY

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