KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON
Device Facts
| Record ID | K911801 |
|---|---|
| Device Name | KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON |
| Applicant | Gds Technology, LLC |
| Product Code | JIN · Clinical Chemistry |
| Decision Date | Jul 1, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1435 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.
