510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082823Substantially Equivalent

Hevylite Human Iga Kappa and Iga Lambda Bn Kits

The Binding Site Group Ltd., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K082823 is the FDA 510(k) clearance record for HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS, a class II device, cleared for The Binding Site Group , Ltd. on under FDA product code CFN (Method, Nephelometric, Immunoglobulins (G, A, M)). FDA records list 44 510(k) clearances for The Binding Site Group , Ltd., from to . As of , FDA records show no recalls naming K082823.

Clearance record

Decision date
Received
(522 days to decision)
Product code
CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
The Binding Site Group , Ltd. 12100 Wilshire Blvd., Los Angeles CA
510(k) summary
Statement
Third party review
No

Clearances, product code CFN

Trailing 12 months

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

FDA records show no clearances under product code CFN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CFN, 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