Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1575](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1575) → JNT — Chromatographic, Phospholipids

# JNT · Chromatographic, Phospholipids

_Clinical Chemistry · 21 CFR 862.1575 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNT

## Overview

- **Product Code:** JNT
- **Device Name:** Chromatographic, Phospholipids
- **Regulation:** [21 CFR 862.1575](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1575)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNT/K922792.md) | ZITHROMAX | Difco Laboratories, Inc. | Jul 30, 1992 | SESE |
| [K914040](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNT/K914040.md) | PHOSPHOLIPID REAGENT SET | Sterling Diagnostics, Inc. | Oct 30, 1991 | SESE |
| [K792349](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNT/K792349.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNT](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNT)

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