N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)— 510(k) K233663

Name: FDA 510(k) clearance K233663
Creator: U.S. Food and Drug Administration
Published: 2023-12-13

Substantially Equivalent

Siemens Healthcare Diagnostics Products GmbH

FDA 510(k) clearance K233663 for N Antisera to Human Immunoglobulins (IgG, IgA, and IgM), Substantially Equivalent on 2023-12-13. Applicant: Siemens Healthcare Diagnostics Products GmbH. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics Products GmbH
Product code: Code CFN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2023-11-15
Decision date: 2023-12-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Marburg, DE

Download summary PDF View on FDA.gov ↗

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