Class Class II
BinaxNOW COVID-19 Ag Card (K250273)
Description
BinaxNOW COVID-19 Ag Card by Abbott Diagnostics Scarborough, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250273
Clearance Date2025-06-13
Clearance TypeDual Track
Product CodeQVF
Regulation Number866.3982
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250273
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. BinaxNOW COVID-19 Ag Card (K250273) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231187 | Nano-CheckĀ COVID-19 Antigen Test | Nano-Ditech Corporation | 2024 |
Trace the full predicate network for K250273
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.