Source document or public record
FDA 510(k) K243410 — simpli-COLLECT STI Test
FDA 510(k) index record K243410. Device: simpli-COLLECT STI Test. Applicant as listed: Abbott Molecular. Decision date: 2025-01-30.
Source
"device_name": "simpli-COLLECT STI Test"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K243410.
Device name: simpli-COLLECT STI Test. Applicant as listed: Abbott Molecular.
Decision date: 2025-01-30. Decision wording: Substantially Equivalent.
Product code: QYA. Regulation: 21 CFR 866.3385. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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