510(k) DEN200070
- Device
- Simple 2 Test
- Applicant
- Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.)
- 510(k) number
- DEN200070
- Product code
- QYA
- Decision
- Unknown (DENG)
- Decision date
- 2023-11-15
- Date received
- 2020-11-16
- Regulation
- 866.3385
- Classification name
- System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Karen Walsh
- Address
- Unit 3, Adelphi House, George'S St. Upper Dun Laoghaire IE A96 NY82 A96 NY82
FDA Registration Numbers#
- 3015209536
- 3005248192
- 3020139194
- 3042854290
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QYA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243410 | simpli-COLLECT STI Test | Abbott Molecular | 2025-01-30 |