K-number	K183176
Device name	Endotoxin Activity Assay (EAA)
Applicant	Spectral Medical, Inc.
Product code	NGS
Device class	Class II
Decision date	Mar 12, 2019
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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Endotoxin Activity Assay (EAA)

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