KZQ · Chromatography(Gas), Clinical Use
Clinical Chemistry · 21 CFR 862.2250 · Class 1
Overview
| Product Code | KZQ |
|---|---|
| Device Name | Chromatography(Gas), Clinical Use |
| 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 (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K872122 | 8000 SERIES GAS CHROMATOGRAPHS | The Perkin-Elmer Corp. | Jun 17, 1987 | SESE |
| K841891 | VARIAN 3300 & 3400 GAS CHROMATOGRAPHS | Varian Assoc., Inc. | Jul 9, 1984 | SESE |
| K832962 | GAS CHROMATOGRAPH 5890A | Hewlett-Packard Co. | Oct 28, 1983 | SESE |
| K831387 | HS-100 HEADSPACE SAMPLING ACCESSORY | The Perkin-Elmer Corp. | Aug 24, 1983 | SESE |
| K830147 | SIGMA 300 GAS CHROMATROGRAPH | The Perkin-Elmer Corp. | Feb 7, 1983 | SESE |
| K820283 | SIGMA 2000 GAS CHROMATOGRAPH | The Perkin-Elmer Corp. | Feb 23, 1982 | SESE |
| K820025 | TRACE ANALYTICAL REDUCTION GAS ANALYZ | Trace Analytical | Feb 15, 1982 | SESE |
| K820071 | MODEL 5790 GAS CHROMATOGRAPH | Hewlett-Packard Co. | Jan 28, 1982 | SESE |
| K801745 | VISTA 44 GAS CHROMATOGRAPHY ANALYSIS | Varian Assoc., Inc. | Aug 20, 1980 | SESE |
| K791138 | 5880 SERIES OF GAS CHROMATOGRAPHS | Hewlett-Packard Co. | Jul 24, 1979 | SESE |
| K770639 | DETECTOR, IR, MODEL GC-33 | Peokin-Elmer Corp. | Jun 24, 1977 | SESE |
| K770025 | GAS CHROMOTOGRAPHS, SIGMA 1,2,3,4,&10 | The Perkin-Elmer Corp. | Feb 16, 1977 | SESE |
Top Applicants
- The Perkin-Elmer Corp. — 5 clearances
- Hewlett-Packard Co. — 3 clearances
- Varian Assoc., Inc. — 2 clearances
- Peokin-Elmer Corp. — 1 clearance
- Trace Analytical — 1 clearance
