Product code JLI

Device name

Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid

Medical specialty

Clinical Chemistry

Device class

1

Regulation number

862.1305

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