← FDA Medical Device Classifications

Igg, Antigen, Antiserum, Control

DEW · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5510

Classification

FDA Product Code

DEW

Device class

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

Regulation

21 CFR 866.5510

Review panel

IM

Medical specialty

Immunology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

76

Registered establishments

25

Source

Authoritative

FDA Device Classification database

Machine

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