K243410
- 510(k) number
- K243410
- Device name
- simpli-COLLECT STI Test
- Applicant
- Abbott Molecular IL · US
- Product code
- QYA — System For Detection Of Nucleic Acid From Non-Viral
- Decision date
- 2025-01-30
- Date received
- 2024-11-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243410.pdf
Official FDA record: K243410
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.