510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K913667Substantially Equivalent

Antithrombin III Immunological Nl Test Kit

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

K913667 is the FDA 510(k) clearance record for ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT, a class II device, cleared for The Binding Site, Ltd. on under FDA product code JBQ (Antithrombin Iii Quantitation). FDA records list 125 510(k) clearances for The Binding Site, Ltd., from to . As of , FDA records show no recalls naming K913667.

Clearance record

Decision date
Received
(137 days to decision)
Product code
JBQ Antithrombin Iii Quantitation
Regulation
21 CFR 864.7060
Device class
Class II
Review panel
Hematology
Applicant
The Binding Site, Ltd. Westside Towers, Suite 1000, Los Angeles CA
510(k) summary
Statement
Third party review
No

Clearances, product code JBQ

Trailing 12 months

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

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