510(k) K183176 ยท NGS Assay, Endotoxin Activity, Chemiluminescent
Endotoxin Activity Assay (EAA)
| Applicant | Spectral Medical, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Mar 12, 2019 |
| Received | Nov 16, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183176
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.