Varian 3300 & 3400 Gas Chromatographs
FDA 510(k) K841891 · Varian Assoc., Inc.
510(k) numberK841891
Submission
- Device name
- Varian 3300 & 3400 Gas Chromatographs
- Applicant
- Varian Assoc., Inc.
Mchenry, IL, US - Received
- May 7, 1984
- Decision date
- July 9, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KZQ – Chromatography(Gas), Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2250
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KZQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K872122 | 8000 Series Gas ChromatographsKZQ · Traditional | The Perkin-Elmer Corp. | 06/17/1987SE |
| K832962 | Gas Chromatograph 5890AKZQ · Traditional | Hewlett-Packard Co. | 10/28/1983SE |
| K831387 | HS-100 Headspace Sampling AccessoryKZQ · Traditional | The Perkin-Elmer Corp. | 08/24/1983SE |
| K830147 | Sigma 300 Gas ChromatrographKZQ · Traditional | The Perkin-Elmer Corp. | 02/07/1983SE |
| K820283 | Sigma 2000 Gas ChromatographKZQ · Traditional | The Perkin-Elmer Corp. | 02/23/1982SE |
| K820025 | Trace Analytical Reduction Gas AnalyzKZQ · Traditional | Trace Analytical | 02/15/1982SE |
| K820071 | Model 5790 Gas ChromatographKZQ · Traditional | Hewlett-Packard Co. | 01/28/1982SE |
| K801745 | Vista 44 Gas Chromatography AnalysisKZQ · Traditional | Varian Assoc., Inc. | 08/20/1980SE |
| K791138 | 5880 Series of Gas ChromatographsKZQ · Traditional | Hewlett-Packard Co. | 07/24/1979SE |
| K770639 | Detector, Ir, Model GC-33KZQ · Traditional | Peokin-Elmer Corp. | 06/24/1977SE |
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| K955774 | Varis PortalvisionIYE · Traditional | 03/15/1996SE |
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Questions and answers
When was Varian 3300 & 3400 Gas Chromatographs cleared by the FDA?
Varian 3300 & 3400 Gas Chromatographs (K841891) received a 510(k) decision of Substantially Equivalent on July 9, 1984, 63 days after the submission was received.
What is the product code of K841891?
The FDA product code is KZQ – Chromatography(Gas), Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2250.