DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
Summary
Diasys Diagnostic Systems GmbH received 510(k) clearance for DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls, a PTF device. Cleared on 2025-05-09.
Details
Source
510(k) Clearance
External ID
K242294
Action Date
2025-05-09
Status
Traditional
Category
device
Product Code
PTF
Product Description
DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls. Product code: PTF.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 389 device clearances issued this month.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Diasys Diagnostic Systems GmbH have FDA actions?
This is the only FDA action we have on record for Diasys Diagnostic Systems GmbH in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K242294" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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