← FDA Medical Device Classifications

Cells, Animal And Human, Cultured

KIR · Class I — Low Risk (general controls) · Hematology · 21 CFR 864.2280

Classification

FDA Product Code

KIR

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 864.2280

Review panel

PA

Medical specialty

Hematology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

170

Registered establishments

7

Source

Authoritative

FDA Device Classification database

Machine

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