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JCG · Class I — Low Risk (general controls) · Hematology · 21 CFR 864.8200

Classification

FDA Product Code
JCG
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 864.8200
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
1

Source

Authoritative
FDA Device Classification database
Machine
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