Chromatography(Gas), Clinical Use
The Clinical Use Gas Chromatography system is a laboratory analytical instrument used in clinical chemistry to separate and identify compounds in biological samples, such as measuring drug concentrations, detecting volatile compounds, or profiling metabolites, based on their differential migration through a stationary phase under a carrier gas. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket submission required. The product code is KZQ, regulated under 21 CFR 862.2250, in the Clinical Chemistry medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KZQ
- Device Class
- FDA class 1
- Regulation Number
- 862.2250
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K872122 | 8000 SERIES GAS CHROMATOGRAPHS | Jun 17, 1987 | Substantially Equivalent | The Perkin-Elmer Corp. |
| K841891 | VARIAN 3300 & 3400 GAS CHROMATOGRAPHS | Jul 09, 1984 | Substantially Equivalent | Varian Assoc., Inc. |
| K832962 | GAS CHROMATOGRAPH 5890A | Oct 28, 1983 | Substantially Equivalent | Hewlett-Packard Co. |
| K831387 | HS-100 HEADSPACE SAMPLING ACCESSORY | Aug 24, 1983 | Substantially Equivalent | The Perkin-Elmer Corp. |
| K830147 | SIGMA 300 GAS CHROMATROGRAPH | Feb 07, 1983 | Substantially Equivalent | The Perkin-Elmer Corp. |
| K820283 | SIGMA 2000 GAS CHROMATOGRAPH | Feb 23, 1982 | Substantially Equivalent | The Perkin-Elmer Corp. |
| K820025 | TRACE ANALYTICAL REDUCTION GAS ANALYZ | Feb 15, 1982 | Substantially Equivalent | Trace Analytical |
| K820071 | MODEL 5790 GAS CHROMATOGRAPH | Jan 28, 1982 | Substantially Equivalent | Hewlett-Packard Co. |
| K801745 | VISTA 44 GAS CHROMATOGRAPHY ANALYSIS | Aug 20, 1980 | Substantially Equivalent | Varian Assoc., Inc. |
| K791138 | 5880 SERIES OF GAS CHROMATOGRAPHS | Jul 24, 1979 | Substantially Equivalent | Hewlett-Packard Co. |
| K770639 | DETECTOR, IR, MODEL GC-33 | Jun 24, 1977 | Substantially Equivalent | Peokin-Elmer Corp. |
| K770025 | GAS CHROMOTOGRAPHS, SIGMA 1,2,3,4,&10 | Feb 16, 1977 | Substantially Equivalent | The Perkin-Elmer Corp. |