Product code JMS

Device name

Acid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase

Medical specialty

Clinical Chemistry

Device class

1

Regulation number

862.1500

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Source

FDA openFDA device classification dataset