Copper Reduction, Glucose
The Copper Reduction, Glucose test system (product code CFW) is an in-vitro diagnostic device used in clinical chemistry to measure glucose concentrations in biological specimens using the copper reduction colorimetric method. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification prior to marketing. It falls under regulation 21 CFR 862.1345 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- CFW
- Device Class
- FDA class 2
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.