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DPM · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.2260

Classification

FDA Product Code
DPM
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 862.2260
Review panel
TX
Medical specialty
Clinical Chemistry
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
16
Registered establishments
5

Source

Authoritative
FDA Device Classification database
Machine
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