# Centers for Disease Control and Prevention

- Location (FDA's records): Atlanta, GA
- FDA decisions: 33 (1981–2026): 28 510(k) clearances, 4 De Novo grants and 1 original PMA approval
- Product codes: OZE (10), PBK (5), OQW (4), LHL (2), SGA (2), NHT (2), NXD (2), LTQ (1), GMQ (1), OEP (1), OZB (1), PDY (1)
- 510(k) review time since 2016: median 4 days, against 2 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 29 (22 its own); citations of its devices by later devices: 33 (22 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Centers For Disease Control and Prevention (CDC): 4 (https://510kreport.com/company/centers-for-disease-control-and-prevention-cdc)
- Biofire Defense, LLC: 1 (https://510kreport.com/company/biofire-defense)
- Center For Disease Control and Prevention (Cdc): 1 (https://510kreport.com/company/center-for-disease-control-and-prevention-cdc)
- Prodesse, Inc.: 1 (https://510kreport.com/company/prodesse)

## Firms that cite its devices most
- Centers For Disease Control and Prevention (CDC): 3 (https://510kreport.com/company/centers-for-disease-control-and-prevention-cdc)
- U.S Army Medical Materiel Development Activity: 2 (https://510kreport.com/company/u-s-army-medical-materiel-development-activity)
- Arbor Vita Corportation: 1 (https://510kreport.com/company/arbor-vita-corportation)
- U.S. Army Medical Material Development Command: 1 (https://510kreport.com/company/us-army-medical-material-development-command)
- Focus Diagnostics, Inc.: 1 (https://510kreport.com/company/focus-diagnostics)
- U.S. Army Medical Material Development Acitvity: 1 (https://510kreport.com/company/us-army-medical-material-development-acitvity)
- Gen-Probe Prodesse, Inc.: 1 (https://510kreport.com/company/gen-probe-prodesse)
- Center For Disease Control and Prevention (Cdc): 1 (https://510kreport.com/company/center-for-disease-control-and-prevention-cdc)

## Its most-cited devices
- K080570: CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel (2008), cited by 8
- K132508: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (2013), cited by 4
- K190302: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit (2019), cited by 2
- K111507: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel (2011), cited by 2
- K172091: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit (2017), cited by 2
- DEN060008: Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set (2006), cited by 2

## Recent decisions
- K262368: B. anthracis Real-time PCR Assay (Oct 7, 2026)
- K263035: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A (H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit) (Sep 30, 2026)
- K260812: Francisella tularensis Real-time PCR Assay (Mar 30, 2026)
- K252072: Francisella tularensis Real-time PCR assay (Sep 30, 2025)
- K243274: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) (Jul 11, 2025)
- K243931: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) (Mar 14, 2025)
- K241110: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) (May 21, 2024)
- K222558: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (Aug 30, 2022)

Source page: https://510kreport.com/company/centers-for-disease-control-and-prevention