← FDA Medical Device Classifications

Radioimmunoassay, Lsd (125-I)

DLB · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3580

Classification

FDA Product Code

DLB

Device class

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

Regulation

21 CFR 862.3580

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

7

Registered establishments

7

Source

Authoritative

FDA Device Classification database

Machine

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