CEQ · Molybdenum Blue Method, Phospholipids
Clinical Chemistry · 21 CFR 862.1575 · Class 1
Overview
| Product Code | CEQ |
|---|---|
| Device Name | Molybdenum Blue Method, 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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K863071 | PHOSPHOLIPIDS-E | J. D. Assoc. | Sep 9, 1986 | SESE |
Top Applicants
- J. D. Assoc. — 1 clearance
