← FDA Medical Device Classifications

System, Hemoglobin, Automated

GKR · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.5620

Classification

FDA Product Code

GKR

Device class

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

Regulation

21 CFR 864.5620

Review panel

HE

Medical specialty

Hematology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

39

Registered establishments

30

Source

Authoritative

FDA Device Classification database

Machine

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