← FDA Medical Device Classifications

Control, Hemoglobin, Abnormal

JCM · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.7415

Classification

FDA Product Code

JCM

Device class

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

Regulation

21 CFR 864.7415

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

12

Registered establishments

6

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown