FDA applicant

Centers For Disease Control and Prevention (CDC)

Atlanta, GA6 decisions2014–20180 recalls

FDA records 6 decisions for Centers For Disease Control and Prevention (CDC) (Atlanta, GA) from 2014 to 2018: 5 510(k) clearances and 1 De Novo grant. Most are in product codes OZE (Influenza A And Influenza B Multiplex Nucleic…) and PVQ (Rickettsia Spp. Nucleic Acid Based Detection…). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Centers For Disease Control and Prevention (CDC)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2014high 2 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Centers For Disease Control and Prevention (CDC) by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Centers For Disease Control and…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Centers”

FDA records each applicant name separately; these may or may not be the same firm.

Centers for Disease Control and Prevention 33

Centers For Disease Control and Prevention (CDC)

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Centers”