← FDA Medical Device Classifications

Anti-Sm Antibody, Antigen And Control

LKP · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5100

Classification

FDA Product Code

LKP

Device class

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

Regulation

21 CFR 866.5100

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

28

Registered establishments

17

Source

Authoritative

FDA Device Classification database

Machine

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