NGS · Class II · 21 CFR 866.3210

FDA Product Code NGS: Assay, Endotoxin Activity, Chemiluminescent

Leading manufacturers include 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

About Product Code NGS - Regulatory Context