GenaCheck COVID-19 Rapid Self-Test
Summary
Genabio Diagnostics, Inc. received 510(k) clearance for GenaCheck COVID-19 Rapid Self-Test, a QYT device. Cleared on 2025-09-05.
Details
Source
510(k) Clearance
External ID
K251753
Action Date
2025-09-05
Status
Traditional
Category
device
Product Code
QYT
Product Description
GenaCheck COVID-19 Rapid Self-Test. Product code: QYT.
Company
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. Genabio Diagnostics, Inc. has received 2 total clearances in our database.
Genabio Diagnostics, Inc. has 2 FDA actions in our database, including 2 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 Genabio Diagnostics, Inc. have FDA actions?
Genabio Diagnostics, Inc. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K251753" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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