Product Code: DMG FDA class 1 21 CFR 862.2230

Papers, Ion

Clinical Chemistry

Ion Papers are laboratory materials used in ion-exchange chromatography, serving as a medium for the separation of ionic compounds including drugs and metabolites in clinical chemistry applications. They are a Class 1 device subject to general controls only, with no premarket notification required. The product code is DMG, regulated under 21 CFR 862.2230, within the Clinical Chemistry specialty. No special regulatory flags apply.

510(k)s
0
FEI Numbers
7
Registration Numbers
7
Unique Applicants
0
Years Active

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Basic Information

Product Code
DMG
Device Class
FDA class 1
Regulation Number
862.2230
Medical Specialty
Clinical Chemistry
Review Panel
TX
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

FEI Numbers

This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.