CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit
Summary
Centers for Disease Control and Prevention received 510(k) clearance for 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), a OZE device. Cleared on 2025-07-11.
Details
Source
510(k) Clearance
External ID
K243274
Action Date
2025-07-11
Status
Traditional
Category
device
Product Code
OZE
Product Description
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). 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 403 device clearances issued this month. Centers for Disease Control and Prevention has received 8 total clearances in our database.
Centers for Disease Control and Prevention has 9 FDA actions in our database, including 1 recall and 8 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 9 FDA actions in our database, including 1 recall and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K243274" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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