NGS · Class II · 21 CFR 866.3210

FDA Product Code NGS: Assay, Endotoxin Activity, Chemiluminescent

Leading manufacturers include Spectral Diagnostics, Inc. and Spectral Medical, Inc..

2
Total
1
Cleared
90d
Avg days
2003
Since

FDA 510(k) Cleared Assay, Endotoxin Activity, Chemiluminescent Devices (Product Code NGS)

2 devices
1–2 of 2
Cleared Mar 12, 2019
Endotoxin Activity Assay (EAA)
K183176
Spectral Medical, Inc.
Microbiology · 116d
Not Cleared Jun 16, 2003
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
DEN030002
Spectral Diagnostics, Inc.
Microbiology · 63d

About Product Code NGS - Regulatory Context