← FDA Medical Device Classifications

System, Test, Her-2/Neu, Monitoring

NCW · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.6010

Classification

FDA Product Code

NCW

Device class

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

Regulation

21 CFR 866.6010

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

3

Registered establishments

3

Source

Authoritative

FDA Device Classification database

Machine

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