510(k) K243410
- Device
- simpli-COLLECT STI Test
- Applicant
- Abbott Molecular
- 510(k) number
- K243410
- Product code
- QYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-01-30
- Date received
- 2024-11-01
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Stacy Ferguson
- Address
- 1300 E Touhy Ave. Des Plaines IL US 60018 60018
FDA Registration Numbers#
- 3015209536
- 3005248192
- 3020139194
- 3042854290
Source Documents#
Other 510(k) Records For Product Code QYA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN200070 | Simple 2 Test | Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) | 2023-11-15 |