← FDA Medical Device Classifications

Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase

JMK · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1380

Classification

FDA Product Code

JMK

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 862.1380

Review panel

CH

Medical specialty

Clinical Chemistry

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

16

Registered establishments

5

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown