FDA 510(k) Applications Submitted by Autumn Collasius

FDA 510(k) Number Submission Date Device Name Applicant
K191288 05/13/2019 Acuitas AMR Gene Panel OpGen, Inc.
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


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