Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate
This device is a clinical chemistry reagent system using uridine-5-diphosphoglucose and NAD in an ultraviolet spectrophotometric assay to measure alpha-D-galactose-1-phosphate, used in the diagnosis and monitoring of galactosemia, an inherited metabolic disorder affecting galactose metabolism. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification, under 21 CFR 862.1315, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- JLJ
- Device Class
- FDA class 2
- Regulation Number
- 862.1315
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K860501 | FLAME PHOTOMETER STANDARD | Apr 07, 1986 | Substantially Equivalent | Medical Specialties, Inc. |