NON INVASIVE VASCULAR PROGRAM
Device Facts
| Record ID | K932852 |
|---|---|
| Device Name | NON INVASIVE VASCULAR PROGRAM |
| Applicant | D. E. Hokanson, Inc. |
| Product Code | JOB · Clinical Chemistry |
| Decision Date | Feb 4, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1815 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A vitamin E test system is a device intended to measure vitamin E (tocopherol) in serum. Measurements obtained by this device are used in the diagnosis and treatment of infants with vitamin E deficiency syndrome.
