simpli-COLLECT STI Test— 510(k) K243410

Substantially Equivalent

Abbott Molecular

FDA 510(k) clearance K243410 for simpli-COLLECT STI Test, Substantially Equivalent on 2025-01-30. Applicant: Abbott Molecular. Device class: 2.

Clearance details

Applicant: Abbott Molecular
Product code: Code QYA
Device class: Class 2
Regulation: 21 CFR 866.3385
Advisory panel: Microbiology
Date received: 2024-11-01
Decision date: 2025-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QYA

DEN200070 — Simple 2 Test2023-11-15

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Data sourced from openFDA. This site is unofficial and independent of the FDA.