Product code CJI

Device name

Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes

Medical specialty

Clinical Chemistry

Device class

2

Regulation number

862.1050

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Source

FDA openFDA device classification dataset