DEN200070
- 510(k) number
- DEN200070
- Device name
- Simple 2 Test
- Applicant
- Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) IE
- Product code
- QYA — System For Detection Of Nucleic Acid From Non-Viral
- Decision date
- 2023-11-15
- Date received
- 2020-11-16
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Microbiology
Official FDA record: DEN200070
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.