INNOVANCE Antithrombin— 510(k) K242952

Name: FDA 510(k) clearance K242952
Creator: U.S. Food and Drug Administration
Published: 2025-03-28

Substantially Equivalent

Siemens Healthcare Diagnostic Products GmbH

FDA 510(k) clearance K242952 for INNOVANCE Antithrombin, Substantially Equivalent on 2025-03-28. Applicant: Siemens Healthcare Diagnostic Products GmbH. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostic Products GmbH
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 2024-09-25
Decision date: 2025-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marburg, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code JBQ

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K081769 — INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO52009-05-28
K070301 — HEMOSIL ANTITHROMBIN2007-02-23
K062431 — HEMOSIL LIQUID ANTITHROMBIN2006-09-01
K043007 — BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 2211052005-11-07
K033775 — HEMOSIL LIQUID ANTITHROMBIN XL2004-01-02

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K172286 — Automated Blood Coagulation Analyzer CS-25002017-12-18
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