← FDA Medical Device Classifications

Centrifuge, Blood-Bank For In Vitro Diagnostic Use

KSO · Class I — Low Risk (general controls) · Hematology · 21 CFR 864.9275

Classification

FDA Product Code

KSO

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 864.9275

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

1

Registered establishments

17

Source

Authoritative

FDA Device Classification database

Machine

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