510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K931806Substantially Equivalent

Iga Subclass Rid Kit for Diagnostic Use

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

K931806 is the FDA 510(k) clearance record for IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE, a class II device, cleared for The Binding Site, Ltd. on under FDA product code CZP (Iga, Antigen, Antiserum, Control). FDA records list 125 510(k) clearances for The Binding Site, Ltd., from to . As of , FDA records show no recalls naming K931806.

Clearance record

Decision date
Received
(95 days to decision)
Product code
CZP Iga, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
The Binding Site, Ltd. Westside Towers, Suite 1000, Los Angeles CA
510(k) summary
Statement
Third party review
No

Clearances, product code CZP

Trailing 12 months

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

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