510(k) K221925 ยท QWR Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
ID NOW COVID-19 2.0
| Applicant | Abbott Diagnostics Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Aug 10, 2023 |
| Received | Jul 1, 2022 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K221925
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW COVID-19 2.0 24T
Product Name: ID NOW COVID-19 2.0 24T
Model/Catalog Number: 192-000
Software Version: N/A
Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucle Open, Classified |
QWR | None listed |
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW COVID-19 2.0 24T
Product Name: ID NOW COVID-19 2.0 24T
Model/Catalog Number: 192-000
Software Version: N/A
Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucle Open, Classified |
QWR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.