Centers For Disease Control and Prevention (CDC): FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Centers For Disease Control and Prevention (CDC)” (first 2014, latest 2018), plus 1 De Novo decision, across 4 product codes in 1 review panel. Median 510(k) review time under this name: 32 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 92 |
| 2015 | 1 | 32 |
| 2016 | 1 | 24 |
| 2017 | 1 | 91 |
| 2018 | 1 | 28 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Centers For Disease Control and Prevention (CDC) took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 42 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay | 3 | 3 |
| NHT | Assay, Nucleic Acid Amplification, Bacillus Anthracis | 1 | 1 |
| PRA | Variola Virus Nucleic Acid-Based Detection Assay | 1 | 0 |
| PVQ | Rickettsia Spp. Nucleic Acid Based Detection Assay | 1 | 1 |
Review panels
- Microbiology (6)
Most recent Centers For Disease Control and Prevention (CDC) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181736 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, | OZE | 2018-07-30 | 28 |
| K170940 | Rickettsia Real-time PCR Assay | PVQ | 2017-06-29 | 91 |
| K161556 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit | OZE | 2016-06-30 | 24 |
| K153148 | CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping | OZE | 2015-12-01 | 32 |
| K140426 | ANTHRACIS REAL-TIME PCR ASSAY | NHT | 2014-05-22 | 92 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN160016 | De Novo | Variola Virus Nucleic Acid-Based Detection Assay | 2017-02-06 |
Recalls
openFDA lists no recalls under a recalling firm named Centers For Disease Control and Prevention (CDC).
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Centers for Disease Control and Prevention (26 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Centers For Disease Control and Prevention (CDC)?
FDA lists 5 510(k) clearances under the applicant name “Centers For Disease Control and Prevention (CDC)” (first 2014, latest 2018), plus 1 De Novo decision, across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Centers For Disease Control and Prevention (CDC)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Centers For Disease Control and Prevention (CDC) is 32 days.
Which FDA product codes appear under Centers For Disease Control and Prevention (CDC)?
The most frequent FDA product codes under this applicant name are OZE (Influenza A And Influenza B Multiplex Nucleic Acid Assay, 3); NHT (Assay, Nucleic Acid Amplification, Bacillus Anthracis, 1); PRA (Variola Virus Nucleic Acid-Based Detection Assay, 1).
Next steps
- See all 5 Centers For Disease Control and Prevention (CDC) clearances with predicates and recalls
- Run predicate analysis for product code OZE, Centers For Disease Control and Prevention (CDC)'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.