Cleared Special

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)

K233663 · Siemens Healthcare Diagnostics Products GmbH · Immunology
Dec 2023
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K233663 is an FDA 510(k) clearance for the N Antisera to Human Immunoglobulins (IgG, IgA, and IgM), a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFN), submitted by Siemens Healthcare Diagnostics Products GmbH (Marburg, DE). The FDA issued a Cleared decision on December 13, 2023, 28 days after receiving the submission on November 15, 2023. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K233663 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2023
Decision Date December 13, 2023
Days to Decision 28 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code CFN — Method, Nephelometric, Immunoglobulins (g, A, M)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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