Company ยท US
Centers For Disease Control and Prevention (CDC)
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2018. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 30, 2018 | K181736 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, Centers For Disease Control and Prevention (CDC) | OZE |
| Jun 29, 2017 | K170940 | Rickettsia Real-time PCR Assay Centers For Disease Control and Prevention (CDC) | PVQ |
| Feb 6, 2017 | DEN160016 | Variola virus Real-Time PCR Assay Centers For Disease Control and Prevention (CDC) | PRA |
| Jun 30, 2016 | K161556 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit Centers For Disease Control and Prevention (CDC) | OZE |
| Dec 1, 2015 | K153148 | CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping Centers For Disease Control and Prevention (CDC) | OZE |
| May 22, 2014 | K140426 | ANTHRACIS REAL-TIME PCR ASSAY Centers For Disease Control and Prevention (CDC) | NHT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||