K-number	K000733
Device name	QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
Applicant	Inova Diagnostics, Inc.
Product code	NBT
Device class	Class II
Decision date	May 21, 2001
Decision	Substantially Equivalent
Regulation	866.5785

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View the full FDA submission: accessdata.fda.gov

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QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA

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