← FDA Medical Device Classifications

Control, Hematocrit

GLK · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.8625

Classification

FDA Product Code

GLK

Device class

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

Regulation

21 CFR 864.8625

Review panel

HE

Medical specialty

Hematology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

7

Registered establishments

13

Source

Authoritative

FDA Device Classification database

Machine

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