← FDA Medical Device Classifications

System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer

NBK · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.1860

Classification

FDA Product Code

NBK

Device class

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

Regulation

21 CFR 864.1860

Review panel

PA

Medical specialty

Hematology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

1

Registered establishments

0

Source

Authoritative

FDA Device Classification database

Machine

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