NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT
Device Facts
| Record ID | K950481 |
|---|---|
| Device Name | NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT |
| Applicant | Isolab, Inc. |
| Product Code | JIA · Clinical Chemistry |
| Decision Date | Feb 1, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1310 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.
