← FDA Medical Device Classifications

Radioimmunoassay, Vancomycin

LEH · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3950

Classification

FDA Product Code

LEH

Device class

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

Regulation

21 CFR 862.3950

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

31

Registered establishments

27

Source

Authoritative

FDA Device Classification database

Machine

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