meddevicedb.com FDA Device Reference

HemosIL Liquid Anti-Xa

DEN190032 Class II Direct
Decision Date
2020-09-17
Sponsor / Applicant
Instrumentation Laboratory CO

Technical Specification

510(k) Submission ID DEN190032
Product Code QLU
Medical Specialty / Panel Hematology
Regulation Citation 21 CFR 864.7295
Decision Date 2020-09-17
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

HemosIL Liquid Anti-Xa received FDA 510(k) clearance under submission number DEN190032, sponsored by Instrumentation Laboratory CO. The device was reviewed via the Direct premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2020-09-17.

Classification & Regulation

This clearance is catalogued under FDA product code QLU and 21 CFR 864.7295, within the Hematology review panel as a Class II device.