K-number	K092300
Device name	MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
Applicant	Diagnostic Hybrids, Inc.
Product code	GNW
Device class	Class I
Decision date	Aug 28, 2009
Decision	Substantially Equivalent
Regulation	866.3330

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View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT

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