510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K001127Substantially Equivalent

Anca Combi Diagnostic Kit with If-Aim Technology

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

K001127 is the FDA 510(k) clearance record for ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY, a class II device, cleared for The Binding Site, Ltd. on under FDA product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)). FDA records list 125 510(k) clearances for The Binding Site, Ltd., from to . As of , FDA records show no recalls naming K001127.

Clearance record

Decision date
Received
(149 days to decision)
Product code
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Regulation
21 CFR 866.5660
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 MOB

Trailing 12 months
1 clearance under product code MOB in the twelve months to November 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MOB, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260
November 20260