JNT · Chromatographic, Phospholipids
Clinical Chemistry · 21 CFR 862.1575 · Class 1
Overview
| Product Code | JNT |
|---|---|
| Device Name | Chromatographic, 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 |
|---|---|---|---|---|
| K922792 | ZITHROMAX | Difco Laboratories, Inc. | Jul 30, 1992 | SESE |
| K914040 | PHOSPHOLIPID REAGENT SET | Sterling Diagnostics, Inc. | Oct 30, 1991 | SESE |
| K792349 | SUSCEPTIBILITY DISK, CINOXACIN 100 MCG. | Pfizer, Inc. | Mar 12, 1980 | SESE |
Top Applicants
- Difco Laboratories, Inc. — 1 clearance
- Pfizer, Inc. — 1 clearance
- Sterling Diagnostics, Inc. — 1 clearance
