← FDA Medical Device Classifications

Radioimmunoassay, Barbiturate

DKN · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3150

Classification

FDA Product Code

DKN

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 862.3150

Review panel

TX

Medical specialty

Clinical Toxicology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

4

Registered establishments

2

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown