CEL · Ammonium Molybdate And Ammonium Vanadate, Phospholipids
Clinical Chemistry · 21 CFR 862.1575 · Class 1
Overview
| Product Code | CEL |
|---|---|
| Device Name | Ammonium Molybdate And Ammonium Vanadate, Phospholipids |
| Regulation | 21 CFR 862.1575 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A phospholipid test system is a device intended to measure phospholipids in serum and plasma. Measurements of phospholipids are used in the diagnosis and treatment of disorders involving lipid (fat) 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K905829 | DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS | Kamiya Biomedical Co. | Jan 30, 1991 | SESE |
| K884169 | DU PONT ANALYST THYROID ROTOR | The DU Pont Co. | Jan 24, 1989 | SESE |
| K801076 | WAKO PHOSPHOLIPIDS TEST | Wako Pure Chemical Industries, Ltd. | Jun 30, 1980 | SESE |
Top Applicants
- Kamiya Biomedical Co. — 1 clearance
- The DU Pont Co. — 1 clearance
- Wako Pure Chemical Industries, Ltd. — 1 clearance
