HemosIL Liquid Anti-Xa— 510(k) DEN190032

Clearance details

Applicant

Instrumentation Laboratory CO

Product code

Code QLU

Device class

Class 2

Regulation

21 CFR 864.7295

Advisory panel

Hematology

Date received

2019-06-25

Decision date

2020-09-17

Decision

Unknown

Clearance type

Direct

Location

Bedford, MA, US

• K240315 — INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)2024-10-10
• K223187 — HemosIL Liquid Anti-Xa2023-06-23

• K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM2023-09-29
• K223090 — GEM Premier ChemSTAT2023-01-27
• K223402 — HemosIL von Willebrand Factor Antigen2022-12-09
• K213464 — HemosIL Liquid Anti-Xa2022-10-04
• K213426 — HemosIL ReadiPlasTin2022-08-16