510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250159Substantially Equivalent

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser

The Binding Site Group Ltd., Birmingham, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250159 is the FDA 510(k) clearance record for Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser, a class II device, cleared for The Binding Site Group , Ltd. on under FDA product code SGG (Mass Spectrometric, Immunoglobulins (G, A, M, D, E)). FDA's definition for product code SGG 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...". FDA records list 44 510(k) clearances for The Binding Site Group , Ltd., from to . As of , FDA records show one recall naming K250159.

Clearance record

Decision date
Received
(269 days to decision)
Product code
SGG Mass Spectrometric, Immunoglobulins (G, A, M, D, E)
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
The Binding Site Group , Ltd. 8 Calthorpe Rd., Birmingham, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SGG

Trailing 12 months

FDA records hold no clearances under product code SGG in the trailing twelve months.

FDA records show no clearances under product code SGG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SGG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260