Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
FDA 510(k) clearance K241580 · decided 2024-12-06
Clearance details
- K-number
- K241580
- Device name
- Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
- Applicant
- Abbott Molecular
- Decision
- Substantially Equivalent
- Date received
- 2024-06-03
- Decision date
- 2024-12-06
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- QQX
- Device class
- 2
- Regulation number
- 866.3981
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Des Plaines, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| UroVysion Bladder Cancer Kit (P030052/S030) | Abbott Molecular | 2026-02-18 |
| UroVysion Bladder Cancer Kit (P030052/S029) | Abbott Molecular | 2025-01-29 |
| RealTime CMV Assay (P160044/S005) | Abbott Molecular | 2023-01-13 |
| Abbott RealTime CMV Amplification Kit (09N21-090), Abbott RealTime CMV Control Kit (09N21-080), Abbott RealTime CMV Cali (P160044/S004) | Abbott Molecular | 2022-06-09 |
| UroVysion Bladder Cancer Kit (P030052/S028) | Abbott Molecular | 2022-03-18 |
| Abbott RealTime CMV (P160044/S003) | Abbott Molecular | 2021-03-05 |
| Abbott RealTime HCV Genotype II (P120012/S019) | Abbott Molecular | 2021-03-05 |
| UroVysion Bladder Cancer Kit (P030052/S027) | Abbott Molecular | 2020-12-11 |