Panels › Microbiology › Product code NGS · Class 2
Assay, Endotoxin Activity, Chemiluminescent
Regulation 866.3210
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NGS
| Company | 510(k)s | Recalls |
|---|---|---|
| Spectral Diagnostics, Inc. | 1 | 0 |
| Spectral Medical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 12, 2019 | K183176 | Endotoxin Activity Assay (EAA) Spectral Medical, Inc., CA | NGS |
| Jun 16, 2003 | DEN030002 | ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE Spectral Diagnostics, Inc. | NGS |
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