CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
Summary
Access Bio, Inc. received 510(k) clearance for CareSuperb COVID-19/Flu A&B Antigen Combo Home Test, a SCA device. Cleared on 2025-08-22.
Details
Source
510(k) Clearance
External ID
K251604
Action Date
2025-08-22
Status
Traditional
Category
device
Product Code
SCA
Product Description
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test. Product code: SCA.
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. Access Bio, Inc. has received 2 total clearances in our database.
Access Bio, 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 Access Bio, Inc. have FDA actions?
Access Bio, 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 "K251604" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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