ID NOW COVID-19 2.0
FDA 510(k) clearance K221925 · decided 2023-08-10
Clearance details
- K-number
- K221925
- Device name
- ID NOW COVID-19 2.0
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-07-01
- Decision date
- 2023-08-10
- Days to decision
- 405 days
- Clearance type
- Dual Track
- Product code
- QWR
- Device class
- 2
- Regulation number
- 866.3982
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Scarborough, ME, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Nu recall (Z-1571-2025) | Abbott Diagnostics Scarborough, Inc. | 2025-04-15 |
| Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Nu recall (Z-1574-2025) | Abbott Diagnostics Scarborough, Inc. | 2025-04-15 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NMP22 BladderChek Test (P940035/S017) | Abbott Diagnostics Scarborough, Inc. | 2022-07-12 |
| Alere NMP22 BladderChek Test (P940035/S016) | Abbott Diagnostics Scarborough, Inc. | 2021-06-15 |
| Alere NMP22 BladderChek Test (P940035/S015) | Abbott Diagnostics Scarborough, Inc. | 2018-05-17 |
| MATRITECH NMP22(TM) TEST KIT (P940035/S014) | Abbott Diagnostics Scarborough, Inc. | 2017-02-27 |
| Alere NMP22 BladderChek Test (P940035/S013) | Abbott Diagnostics Scarborough, Inc. | 2016-09-08 |
| ALERE NMP22(TM) TEST (P940035/S012) | Abbott Diagnostics Scarborough, Inc. | 2016-05-06 |
| ALERE NMP22 BLADDERCHEK TEST (P940035/S011) | Abbott Diagnostics Scarborough, Inc. | 2015-07-28 |
| ALERE NMP22 TEST (P940035/S010) | Abbott Diagnostics Scarborough, Inc. | 2013-07-16 |