NGS — Assay, Endotoxin Activity, Chemiluminescent Class II
FDA Device Classification
Classification Details
- Product Code
- NGS
- Device Class
- Class II
- Regulation Number
- 866.3210
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K183176 | spectral medical | Endotoxin Activity Assay (EAA) | March 12, 2019 |
| DEN030002 | spectral diagnostics | ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE | June 16, 2003 |