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FDA 510(k)

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

K-Number: K242294 · 2025-05-09

ApplicantDiasys Diagnostic Systems GmbH
Decision Date2025-05-09
Product CodePTF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls is a medical device manufactured by Diasys Diagnostic Systems GmbH. It received FDA 510(k) clearance on 2025-05-09 under approval number K242294. The device is classified under product code PTF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls?

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls is a medical device that received FDA 510(k) clearance on 2025-05-09. It is manufactured by Diasys Diagnostic Systems GmbH. The 510(k) number is K242294.

When was DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls approved by the FDA?

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls received FDA 510(k) clearance on 2025-05-09, under approval number K242294.

What company makes DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls?

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls is manufactured by Diasys Diagnostic Systems GmbH.

What is the FDA product code for DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls?

The FDA product code for DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls is PTF.

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Related Devices (Code: PTF)

K162297Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control SetDiazyme Laboratories K192271Access PCT, Access PCT CalibratorsBeckman Coulter, Inc. K222996Access PCTBeckman Coulter, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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