Colorimetric, Mucopolysaccharides
The Colorimetric, Mucopolysaccharides test is a clinical chemistry diagnostic device that uses colorimetric methods to detect and quantify mucopolysaccharides (glycosaminoglycans) in urine or other biological specimens, used in the screening and diagnosis of mucopolysaccharidosis storage disorders such as Hurler, Hunter, and Morquio syndromes. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JQN and is regulated under 21 CFR 862.1505, within the Clinical Chemistry medical specialty.
Research product code JQN in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- JQN
- Device Class
- FDA class 1
- Regulation Number
- 862.1505
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.