510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914389Substantially Equivalent

Alpha-2 Macroglobulin Test Rid Kit

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

K914389 is the FDA 510(k) clearance record for ALPHA-2 MACROGLOBULIN TEST RID KIT, a class II device, cleared for The Binding Site, Ltd. on under FDA product code DEB (Alpha-2-Macroglobulin, 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 K914389.

Clearance record

Decision date
Received
(80 days to decision)
Product code
DEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5620
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 DEB

Trailing 12 months

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

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