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
K162297 Diazyme Laboratories Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set 04/18/2017


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