510(k) DEN190025 ยท QID Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
OraQuick Ebola Rapid Antigen Test
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Unknown, Oct 10, 2019 |
| Received | May 13, 2019 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN190025
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.