Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)
Metallic Reduction Method for Glucose (Urinary, Non-Quantitative) is a clinical chemistry test system that detects glucose in urine by its ability to reduce metallic salts, providing a non-quantitative screening result for glucosuria associated with diabetes or renal disease. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is JIM, regulated under 21 CFR 862.1340, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- JIM
- Device Class
- FDA class 2
- Regulation Number
- 862.1340
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.