The following data is part of a De Novo classification by Spectral Diagnostics, Inc. with the FDA for Endotoxin Activity Assay (eaa) Device.
| DeNovo ID | DEN030002 |
| Device Name: | ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE |
| Classification | Assay, Endotoxin Activity, Chemiluminescent |
| Applicant | SPECTRAL DIAGNOSTICS, INC. 16809 Briardale Rd. Rockville, MD 20855 |
| Contact | Tom Tsakeris |
| Product Code | NGS |
| CFR Regulation Number | 866.3210 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K021885 |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Post-NSE |
| Date Received | 2003-04-14 |
| Decision Date | 2003-06-16 |
| Reclassification Order: | Reclassification Order |