| Device Type ID | 3505 |
| Device Name | Assay, Endotoxin Activity, Chemiluminescent |
| Regulation Description | Endotoxin Assay. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3210 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NGS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3505 |
| Device | Assay, Endotoxin Activity, Chemiluminescent |
| Product Code | NGS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endotoxin Assay. |
| CFR Regulation Number | 866.3210 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SPECTRAL MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |