JLG · Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids
Clinical Chemistry · 21 CFR 862.1290 · Class 1
Overview
| Product Code | JLG |
|---|---|
| Device Name | Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids |
| Regulation | 21 CFR 862.1290 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A fatty acids test system is a device intended to measure fatty acids in plasma and serum. Measurements of fatty acids are used in the diagnosis and treatment of various disorders of lipid metabolism.
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 the limitations in § 862.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K812081 | WAKO NEFA C TEST | Wako Chemicals USA, Inc. | Aug 12, 1981 | SESE |
| K760750 | STERILE TUBULAR UNBLEACHED STOCKINETTE | Dennison Manufacturing Co. | Oct 8, 1976 | SESE |
Top Applicants
- Dennison Manufacturing Co. — 1 clearance
- Wako Chemicals USA, Inc. — 1 clearance
