De Novo DEN180056

Device

GSP Neonatal Creatine Kinase - MM kit

Contact

brian ciccariello

De Novo number

DEN180056

Product code

QJE

Regulation

862.1506

Classification name

muscular dystrophy newborn screening test

Decision

granted (DENG)

Decision date

2019-12-12

Date received

2018-10-11

Classification advisory

Clinical Chemistry

Review advisory

Clinical Chemistry

Type

Direct