INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)— 510(k) K240315

Name: FDA 510(k) clearance K240315
Creator: U.S. Food and Drug Administration
Published: 2024-10-10

Substantially Equivalent

Siemens Healthcare Diagnostics Products GmbH

FDA 510(k) clearance K240315 for INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05), Substantially Equivalent on 2024-10-10. Applicant: Siemens Healthcare Diagnostics Products GmbH. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics Products GmbH
Product code: Code QLU
Device class: Class 2
Regulation: 21 CFR 864.7295
Advisory panel: Hematology
Date received: 2024-02-02
Decision date: 2024-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marburg, DE

Download summary PDF View on FDA.gov ↗

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