STA LIATEST D-DI— 510(k) K141144

Substantially Equivalent

Diagnostica Stago

FDA 510(k) clearance K141144 for STA LIATEST D-DI, Substantially Equivalent on 2014-09-03. Applicant: Diagnostica Stago. Device class: 2.

Clearance details

Applicant: Diagnostica Stago
Product code: Code DAP
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 2014-05-02
Decision date: 2014-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rome, IT

Download summary PDF View on FDA.gov ↗

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More clearances from Diagnostica Stago

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Recalls naming K141144

K-number listed on FDA's recall record

Z-0205-2026 — Product: STA Liatest D-Di; REF: 00515;Class II·Ongoing·Diagnostica Stago, Inc.·20250912

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141144.

Data sourced from openFDA. This site is unofficial and independent of the FDA.