← FDA Medical Device Classifications

Bottle, Roller, Tissue Culture

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

Classification

FDA Product Code
KJC
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
3
Registered establishments
17

Source

Authoritative
FDA Device Classification database
Machine
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