510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SGGClass II

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

21 CFR 866.5510 / Immunology
FDA source (opens on fda.gov)

SGG is the FDA product code for Mass Spectrometric, Immunoglobulins (G, A, M, D, E), a class II device type, regulated under 21 CFR 866.5510. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SGG
Device name
Mass Spectrometric, Immunoglobulins (G, A, M, D, E)
FDA 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.
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SGG

By decision year
1 clearance under product code SGG with a decision year between 2025 and 2025, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SGG by decision year
YearClearances
20251

Applicants with the most clearances

Product code SGG
Applicants holding the most 510(k) clearances under product code SGG
ApplicantClearances
The Binding Site Group Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code