FDA 510(k) Applications Submitted by Qiagen GmbH

FDA 510(k) Number Submission Date Device Name Applicant
K242256 07/31/2024 QIAstat-Dx Meningitis/Encephalitis (ME) Panel QIAGEN GmbH
K242353 08/08/2024 QIAstat-Dx Respiratory Panel Mini Qiagen GmbH
K233100 09/26/2023 QIAstat-Dx« Respiratory Panel Plus QIAGEN GmbH
K243813 12/11/2024 QIAstat-Dx GI Panel 2 Mini B&V Qiagen GmbH
K250324 02/05/2025 QIAstat-Dx GI Panel 2 Mini B QIAGEN GmbH
K183597 12/21/2018 QIAstat-Dx Respiratory Panel QIAGEN GmbH
K220062 01/10/2022 QIAstat-Dx Gastrointestinal Panel 2 QIAGEN GmbH


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