510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Diasys Diagnostic Systems GmbH

Holzheim Rhineland-Palatinate, DE

DIASYS DIAGNOSTIC SYSTEMS GMBH appears in FDA device records in Holzheim Rhineland-Palatinate, DE. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Diasys Diagnostic Systems GmbH in 2025.

Clearances by year, as a table
510(k) clearance decisions for Diasys Diagnostic Systems GmbH, by decision year
YearClearances
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242294DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level ControlsPTFSubstantially Equivalent

Registered establishments

FDA registered establishments for Diasys Diagnostic Systems GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30066446203006644620DIASYS DIAGNOSTIC SYSTEMS GMBHALTE STRASSE 9, Holzheim Rhineland-Palatinate D-65558 DE2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain