MPG · Urinary Carbohydrate Analysis Kit
Clinical Chemistry · 21 CFR 862.1505 · Class 1
Overview
| Product Code | MPG |
|---|---|
| Device Name | Urinary Carbohydrate Analysis Kit |
| Regulation | 21 CFR 862.1505 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A mucopolysaccharides (nonquantitative) test system is a device intended to measure the levels of mucopolysaccharides in urine. Mucopolysaccharide measurements in urine are used in the diagnosis and treatment of various inheritable disorders that affect bone and connective tissues, such as Hurler's, Hunter's, Sanfilippo's, Scheie's Morquio's and Maroteaux-Lamy syndromes.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K945519 | FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM | Pharmaquest Corp. | Nov 3, 1995 | SESE |
Top Applicants
- Pharmaquest Corp. — 1 clearance
