510(k) DEN030002 ยท NGS Assay, Endotoxin Activity, Chemiluminescent
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
| Applicant | Spectral Diagnostics, Inc., Rockville MD, US |
| Decision | Unknown, Jun 16, 2003 |
| Received | Apr 14, 2003 |
| Type | Post-NSE |
| FDA record | Open on fda.gov |
Recalls that name DEN030002
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.