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Apparatus, Automated Blood Cell Diluting

GKH · Class I — Low Risk (general controls) · Hematology · 21 CFR 864.5240

Classification

FDA Product Code

GKH

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 864.5240

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

14

Registered establishments

5

Source

Authoritative

FDA Device Classification database

Machine

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