Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Diasys Diagnostic Systems GmbH. It received FDA 510(k) clearance on 2025-05-09 under 510(k) 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. The listed applicant is Diasys Diagnostic Systems GmbH. The 510(k) number is K242294.

When did DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls receive FDA 510(k) clearance?

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

Who is the listed applicant for DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls?

The FDA 510(k) record lists Diasys Diagnostic Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07193199New Technique and Product for Chin EnhancementCOMPLETED

Related Devices (Code: PTF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

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.

↑