510(k) clearance

STA® - Liquid Anti-Xa

FDA 510(k) source

510(k) number

K260214

Applicant

Diagnostica Stago, Inc.

Decision date

Sep 24, 2026

Date received

Jan 23, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

KFF

Device type

Assay, Heparin

Device class

Class II

Regulation

21 CFR 864.7525

Advisory committee

Hematology

Statement or summary

Summary

Third party

N

Location

Parsippany, NJ, US