DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls— 510(k) K242294

Name: FDA 510(k) clearance K242294
Creator: U.S. Food and Drug Administration
Published: 2025-05-09

Substantially Equivalent

Diasys Diagnostic Systems GmbH

FDA 510(k) clearance K242294 for DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls, Substantially Equivalent on 2025-05-09. Applicant: Diasys Diagnostic Systems GmbH. Device class: 2.

Clearance details

Applicant: Diasys Diagnostic Systems GmbH
Product code: Code PTF
Device class: Class 2
Regulation: 21 CFR 866.3215
Advisory panel: Microbiology
Date received: 2024-08-02
Decision date: 2025-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holzheim, DE

Download summary PDF View on FDA.gov ↗

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