FDA 510(k) Applications for Medical Device Product Code: PTF ()

FDA 510(k) Applications for Medical Device Product Code "PTF"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K222996	Beckman Coulter, Inc	Access PCT	04/26/2023
K192271	Beckman Coulter, Inc.	Access PCT, Access PCT Calibrators	11/26/2019
K242294	DiaSys Diagnostic Systems GmbH	DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls	05/09/2025
K162297	Diazyme Laboratories	Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set	04/18/2017