JSQ · Chromatography For Bacterial Identification
Clinical Chemistry · 21 CFR 862.2250 · Class 1
Overview
| Product Code | JSQ |
|---|---|
| Device Name | Chromatography For Bacterial Identification |
| Regulation | 21 CFR 862.2250 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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 | CYSTINE TRYPTIC MEDIUM | Micro Media Laboratories | Dec 22, 1983 | SESE |
| K811138 | NUTRIENT AGAR | Acumedia Manufacturers, Inc. | May 5, 1981 | SESE |
| K761226 | GP3%SP-2100DOHON100/120 MESH SUPELCOPORT | Supelco, Inc. | Jan 14, 1977 | SESE |
Top Applicants
- Acumedia Manufacturers, Inc. — 1 clearance
- Micro Media Laboratories — 1 clearance
- Supelco, Inc. — 1 clearance
