K-number	DEN030002
Device name	ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
Applicant	Spectral Diagnostics, Inc.
Product code	NGS
Device class	Class II
Decision date	Jun 16, 2003
Decision	Not Substantially Equivalent
Regulation	—

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ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE

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