DeviceClearance

QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini— 510(k) K250080

Substantially Equivalent

QIAGEN GmbH

FDA 510(k) clearance K250080 for QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini, Substantially Equivalent on 2025-08-27. Applicant: QIAGEN GmbH.

Clearance details

Applicant
QIAGEN GmbH
Product code
Code QOF
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hilden, DE
Download summary PDFView on FDA.gov ↗

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