JOB · Hexane Extraction, Fluorescence, Vitamin E
Clinical Chemistry · 21 CFR 862.1815 · Class 1
Overview
| Product Code | JOB |
|---|---|
| Device Name | Hexane Extraction, Fluorescence, Vitamin E |
| Regulation | 21 CFR 862.1815 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 subject to the limitations in § 862.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K932852 | NON INVASIVE VASCULAR PROGRAM | D. E. Hokanson, Inc. | Feb 4, 1994 | SESE |
Top Applicants
- D. E. Hokanson, Inc. — 1 clearance
