FDA 510(k) Application Details - K243410

Device Classification Name	More FDA Info for this Device
510(K) Number	K243410
Device Name	simpli-COLLECT STI Test
Applicant	Abbott Molecular 1300 E Touhy Ave Des Plaines, IL 60018 US Other 510(k) Applications for this Company
Contact	Stacy Ferguson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2024
Decision Date	01/30/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review