CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Ki
Summary
Centers for Disease Control and Prevention received 510(k) clearance for 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), a OZE device. Cleared on 2026-09-30.
Details
Source
510(k) Clearance
External ID
K263035
Action Date
2026-09-30
Status
Special
Category
device
Product Code
OZE
Product Description
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). Product code: OZE.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 502 device clearances issued this month. Centers for Disease Control and Prevention has received 10 total clearances in our database.
Centers for Disease Control and Prevention has 11 FDA actions in our database, including 1 recall and 10 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Centers for Disease Control and Prevention have FDA actions?
Centers for Disease Control and Prevention has 11 FDA actions in our database, including 1 recall and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K263035" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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