← FDA Medical Device Classifications

Cholinesterase Test Paper

DIG · Class I — Low Risk (general controls) · Clinical Toxicology · 21 CFR 862.3240

Classification

FDA Product Code

DIG

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 862.3240

Review panel

TX

Medical specialty

Clinical Toxicology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

1

Registered establishments

1

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown