← FDA Medical Device Classifications

Hemoglobin, Chain Specific, Antigen, Antiserum, Control

DAM · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5470

Classification

FDA Product Code

DAM

Device class

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

Regulation

21 CFR 866.5470

Review panel

IM

Medical specialty

Immunology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

0

Registered establishments

2

Source

Authoritative

FDA Device Classification database

Machine

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