510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K004019Substantially Equivalent

Ana Eia Diagnostic Test Kit

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

K004019 is the FDA 510(k) clearance record for ANA EIA DIAGNOSTIC TEST KIT, a class II device, cleared for The Binding Site, Ltd. on under FDA product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls). FDA records list 125 510(k) clearances for The Binding Site, Ltd., from to . As of , FDA records show no recalls naming K004019.

Clearance record

Decision date
Received
(50 days to decision)
Product code
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
The Binding Site, Ltd. West Tower, Suite 4000, Santa Monica CA
510(k) summary
Statement
Third party review
No

Clearances, product code LJM

Trailing 12 months

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

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