ID NOW COVID-19 2.0— 510(k) K221925
Substantially EquivalentAbbott Diagnostics Scarborough, Inc.
FDA 510(k) clearance K221925 for ID NOW COVID-19 2.0, Substantially Equivalent on 2023-08-10. Applicant: Abbott Diagnostics Scarborough, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Product code
- Code QWR
- Device class
- Class 2
- Regulation
- 21 CFR 866.3982
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Scarborough, ME, US
Recent devices under product code QWR
view allMore clearances from Abbott Diagnostics Scarborough, Inc.
view allRecalls naming K221925
K-number listed on FDA's recall record- Z-1571-2025 — 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 Nucleic Acid Targets Component: No
- Z-1574-2025 — 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 Nucleic Acid Targets Component: No
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K221925.
Data sourced from openFDA. This site is unofficial and independent of the FDA.