meddevicedb.com FDA Device Reference

ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M

DEN160047 Class II Direct
Decision Date
2017-06-29
Sponsor / Applicant
Beckman Coulter

Technical Specification

510(k) Submission ID DEN160047
Product Code PWD
Medical Specialty / Panel Hematology
Regulation Citation 21 CFR 864.7010
Decision Date 2017-06-29
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

ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M received FDA 510(k) clearance under submission number DEN160047, sponsored by Beckman Coulter. The device was reviewed via the Direct premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2017-06-29.

Classification & Regulation

This clearance is catalogued under FDA product code PWD and 21 CFR 864.7010, within the Hematology review panel as a Class II device.