FDA.report

510(k) K250324

Device
QIAstat-Dx GI Panel 2 Mini B
Applicant
QIAGEN GmbH
510(k) number
K250324
Product code
PCH
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-28
Date received
2025-02-05
Regulation
866.3990
Classification name
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Kristen Kanack
Address
Qiagen Strasse 1 Hilden DE 40724 40724

FDA Registration Numbers

Source Documents

510(k) summary PDF

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