K-number	DEN100020
Device name	DENV DETECT IGM CAPTURE ELISA
Applicant	Inbios Intl., Inc.
Product code	OSU
Device class	Class II
Decision date	Apr 8, 2011
Decision	Not Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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DENV DETECT IGM CAPTURE ELISA

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