510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161854Substantially Equivalent

Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS

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

K161854 is the FDA 510(k) clearance record for Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS, a class II device, cleared for The Binding Site Group , Ltd. on under FDA product code PCN (Immunoglobulin G Kappa Heavy And Light Chain Combined). FDA's definition for product code PCN reads: "Intended for the in-vitro quantification of IgG kappa concentration in human serum". FDA records list 44 510(k) clearances for The Binding Site Group , Ltd., from to . As of , FDA records show no recalls naming K161854.

Clearance record

Decision date
Received
(90 days to decision)
Product code
PCN Immunoglobulin G Kappa Heavy And Light Chain Combined
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
The Binding Site Group , Ltd. 8 Calthorpe Rd., Edgbaston, GB
510(k) summary
Statement
Third party review
No

Clearances, product code PCN

Trailing 12 months

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

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