Simple 2 Test
FDA 510(k) clearance DEN200070 · decided 2023-11-15
Clearance details
- K-number
- DEN200070
- Device name
- Simple 2 Test
- Applicant
- Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.)
- Decision
- Unknown
- Date received
- 2020-11-16
- Decision date
- 2023-11-15
- Days to decision
- 1094 days
- Clearance type
- Direct
- Product code
- QYA
- Device class
- 2
- Regulation number
- 866.3385
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Dun Laoghaire, IE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| simpli-COLLECT STI Test (K243410) | Abbott Molecular | 2025-01-30 |
Recalls involving this device
No recalls on record reference this clearance.