JAYCO HYDROGEN MONITOR
Device Facts
| Record ID | K882499 |
|---|---|
| Device Name | JAYCO HYDROGEN MONITOR |
| Applicant | Enteron, Inc. |
| Product Code | NRH · Clinical Chemistry |
| Decision Date | Jun 28, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1820 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A xylose test system is a device intended to measure xylose (a sugar) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption syndrome (a group of disorders in which there is subnormal absorption of dietary constituents and thus excessive loss from the body of the nonabsorbed substances).
