FDA 510(k) Application Details - K220062

Device Classification Name	More FDA Info for this Device
510(K) Number	K220062
Device Name	QIAstat-Dx Gastrointestinal Panel 2
Applicant	QIAGEN GmbH QIAGEN Strasse 1 Hilden 40724 DE Other 510(k) Applications for this Company
Contact	Stephany Foster Spahr 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	01/10/2022
Decision Date	05/31/2024
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