CFN

Method, Nephelometric, Immunoglobulins (G, A, M)

Product code
CFN
Device name
Method, Nephelometric, Immunoglobulins (G, A, M)
Device class
Class 2
21 CFR
21 CFR 866.5510
Medical specialty
Immunology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
61 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-12-13.

NumberDecision dateApplicantDevice nameSummary
K2336632023-12-13Siemens Healthcare Diagnostics Product…N Antisera to Human Immunoglobulins (IgG, IgA, and I…PDF

1 summaries are archived here for direct download.

Official FDA classification page: CFN
Classification and pathway per current FDA publications. Data from openFDA (CC0).