FDA 510(k) Application Details - K242294

Device Classification Name	More FDA Info for this Device
510(K) Number	K242294
Device Name	DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
Applicant	DiaSys Diagnostic Systems GmbH Alte Strasse 9 Holzheim 65558 DE Other 510(k) Applications for this Company
Contact	Jan Gorka Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PTF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2024
Decision Date	05/09/2025
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