← FDA Medical Device Classifications

Calibrator For Red-Cell And White-Cell Counting

KSA · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.8185

Classification

FDA Product Code

KSA

Device class

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

Regulation

21 CFR 864.8185

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

8

Registered establishments

15

Source

Authoritative

FDA Device Classification database

Machine

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