FDA 510(k) Applications for Medical Device Product Code "NGS"
(Assay, Endotoxin Activity, Chemiluminescent)

FDA 510(k) Number Applicant Device Name Decision Date
DEN030002 SPECTRAL DIAGNOSTICS, INC. ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE 06/16/2003
K183176 Spectral Medical Inc. Endotoxin Activity Assay (EAA) 03/12/2019


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