510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983694Substantially Equivalent

Anticardiolipin Igm Screen Eia Diagnostic Test Kit

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

K983694 is the FDA 510(k) clearance record for ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT, a class II device, cleared for The Binding Site, Ltd. on under FDA product code MID (System, Test, Anticardiolipin Immunological). FDA records list 125 510(k) clearances for The Binding Site, Ltd., from to . As of , FDA records show one recall naming K983694.

Clearance record

Decision date
Received
(107 days to decision)
Product code
MID System, Test, Anticardiolipin Immunological
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
The Binding Site, Ltd. East Tower, Suite 600, Santa Monica CA
510(k) summary
Statement
Third party review
No

Clearances, product code MID

Trailing 12 months

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

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