De Novo DEN160047

Device

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

Contact

anthony dennis

De Novo number

DEN160047

Product code

PWD

Regulation

864.7010

Classification name

flow cytometric test system for hematopoietic neoplasms

Decision

granted (DENG)

Decision date

2017-06-29

Date received

2016-10-03

Classification advisory

Hematology

Review advisory

Immunology

Type

Direct