SGG

Mass Spectrometric, Immunoglobulins (G, A, M, D, E)

Product code

SGG

Device name

Mass Spectrometric, Immunoglobulins (G, A, M, D, E)

Device class

Class 2

21 CFR

21 CFR 866.5510

Medical specialty

Immunology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

The test system is intended for the (semi-)quantitative or quantitative determination of monoclonal immunoglobulins (M-proteins) and/or the identification of Immunoglobulin isotype of M-proteins in human specimens by mass spectrometric methods.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

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

Last three years. Most recent: 2025-10-17.

1 summaries are archived here for direct download.