← FDA Medical Device Classifications

Enzyme Immunoassay, Opiates

DJG · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3650

Classification

FDA Product Code

DJG

Device class

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

Regulation

21 CFR 862.3650

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

215

Registered establishments

98

Source

Authoritative

FDA Device Classification database

Machine

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