510(k) Report

FDA applicant

Center For Disease Control and Prevention (Cdc)

Atlanta, GA1 decision2014–20140 recalls

FDA records 1 decision for Center For Disease Control and Prevention (Cdc) (Atlanta, GA) in 2014: 1 510(k) clearance. All are in product code OZE (Influenza A And Influenza B Multiplex Nucleic…). Its devices cite 1 predicate, 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 Center For Disease Control and Prevention (Cdc)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

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

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Which product codes does it file in?

  • OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K133869CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza a/B Typing KitCenter For Disease Control and Prevention (Cdc) · 20141cites it

What has FDA decided for it lately?

  • K133869CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza a/B Typing KitCenter For Disease Control and Prevention (Cdc) · 2014

The one decision as Center For Disease Control and Prevention (Cdc) →

Other applicant names beginning “Center”

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

Center Laboratories, Inc. 2Center For Biomaterials and Advanced Technologies 1Center For Marketing Services 1The Center For Craniofacial & Dental Sleep Medicine 1Center For Orthotic and Prosthetic Care,Llc 1