NRH · System, Breath Measurement
Clinical Chemistry · 21 CFR 862.1820 · Class 1
Overview
| Product Code | NRH |
|---|---|
| Device Name | System, Breath Measurement |
| Regulation | 21 CFR 862.1820 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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).
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.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K033688 | MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY | Micro Direct, Inc. | May 19, 2004 | SESE |
| K963376 | MICRO H2 | Micro Direct, Inc. | Jan 24, 1997 | SESE |
| K882499 | JAYCO HYDROGEN MONITOR | Enteron, Inc. | Jun 28, 1988 | SESE |
| K874892 | VITALOGRAPH-EC60 HYDROGEN MONITOR | Vitalograph , Ltd. | Jun 2, 1988 | SESE |
Top Applicants
- Micro Direct, Inc. — 2 clearances
- Vitalograph , Ltd. — 1 clearance
- Enteron, Inc. — 1 clearance
