Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2250](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2250) → JSQ — Chromatography For Bacterial Identification

# JSQ · Chromatography For Bacterial Identification

_Clinical Chemistry · 21 CFR 862.2250 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JSQ

## Overview

- **Product Code:** JSQ
- **Device Name:** Chromatography For Bacterial Identification
- **Regulation:** [21 CFR 862.2250](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2250)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A gas liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. Each of the constituents in a vaporized mixture of compounds is separated according to its vapor pressure. The device may include accessories such as columns, gases, column supports, and liquid coating.

## 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 § 862.9.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K834007](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JSQ/K834007.md) | CYSTINE TRYPTIC MEDIUM | Micro Media Laboratories | Dec 22, 1983 | SESE |
| [K811138](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JSQ/K811138.md) | NUTRIENT AGAR | Acumedia Manufacturers, Inc. | May 5, 1981 | SESE |
| [K761226](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JSQ/K761226.md) | GP3%SP-2100DOHON100/120 MESH SUPELCOPORT | Supelco, Inc. | Jan 14, 1977 | SESE |

## Top Applicants

- Supelco, Inc. — 1 clearance
- Micro Media Laboratories — 1 clearance
- Acumedia Manufacturers, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JSQ](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JSQ)

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