Alinity m STI Assay
FDA 510(k) clearance K202977 · decided 2022-04-29
Clearance details
- K-number
- K202977
- Device name
- Alinity m STI Assay
- Applicant
- Abbott Molecular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-30
- Decision date
- 2022-04-29
- Days to decision
- 576 days
- Clearance type
- Traditional
- Product code
- QEP
- Device class
- 2
- Regulation number
- 866.3393
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Des Plaines, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Alinity m HR HPV (P230003/S009) | Abbott Molecular, Inc. | 2025-10-17 |
| Alinity m HBV (P200013/S027) | Abbott Molecular, Inc. | 2025-10-17 |
| Alinity m HR HPV (P230003/S008) | Abbott Molecular, Inc. | 2025-09-24 |
| Alinity m HBV (P200013/S026) | Abbott Molecular, Inc. | 2025-09-24 |
| Alinity m HR HPV (P230003/S006) | Abbott Molecular, Inc. | 2025-09-10 |
| Vysis CLL Fish Probe Kit (P150041/S007) | Abbott Molecular, Inc. | 2025-08-08 |
| Vysis ALK Break Apart FISH Probe Kit (P110012/S022) | Abbott Molecular, Inc. | 2025-08-05 |
| Alinity m HR HPV (P230003/S007) | Abbott Molecular, Inc. | 2025-04-18 |