510(k) DEN160016 ยท PRA Variola Virus Nucleic Acid-Based Detection Assay
Variola virus Real-Time PCR Assay
| Applicant | Centers For Disease Control and Prevention (CDC), Atlanta GA, US |
| Decision | Unknown, Feb 6, 2017 |
| Received | Apr 14, 2016 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN160016
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.