← FDA Medical Device Classifications

Flask, Tissue Culture

KJA · Class I — Low Risk (general controls) · Hematology · 21 CFR 864.2240

Classification

FDA Product Code

KJA

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 864.2240

Review panel

PA

Medical specialty

Hematology

Submission type

4

GMP exempt

Y

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

13

Registered establishments

31

Source

Authoritative

FDA Device Classification database

Machine

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