FDA 510(k) Application Details - K243813

Device Classification Name	More FDA Info for this Device
510(K) Number	K243813
Device Name	QIAstat-Dx GI Panel 2 Mini B&V
Applicant	Qiagen GmbH Qiagen Strasse 1 Hilden 40724 DE Other 510(k) Applications for this Company
Contact	Autumn Collasius Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2024
Decision Date	01/08/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review