Varian 2000 Liquid Chromatography Analy
FDA 510(k) K841890 · Varian Assoc., Inc.
510(k) numberK841890
Submission
- Device name
- Varian 2000 Liquid Chromatography Analy
- Applicant
- Varian Assoc., Inc.
Mchenry, IL, US - Received
- May 7, 1984
- Decision date
- June 14, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KZR – Chromatography (Liquid, Gel), Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2260
- Specialty
- Clinical Chemistry
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| K973074 | 2487 Dual Wavelength Absorbance DetectorKZR · Traditional | Waters Corporation | 10/06/1997SE |
| K931227 | Usdt Flow Immunoassay System, Model 9000KZR · Traditional | U.S. Drug Testing, Inc. | 05/06/1993SE |
| K905538 | Columns Liquid Chromatography DPMKZR · Traditional | Millpore Corp. | 01/25/1991SE |
| K861392 | Syva Solid Phase Columns System IIKZR · Traditional | Syva Co. | 06/13/1986SE |
| K860197 | Series 410 LC PumpKZR · Traditional | The Perkin-Elmer Corp. | 03/17/1986SE |
| K851945 | Varian Aasp Automated Sample Prep. SystemKZR · Traditional | Varian Assoc., Inc. | 05/24/1985SE |
| K843568 | Liquid Chromatograph 400KZR · Traditional | The Perkin-Elmer Corp. | 11/20/1984SE |
| K840977 | Liquid Chromatographic Detector LC-95KZR · Traditional | The Perkin-Elmer Corp. | 04/19/1984SE |
| K832201 | Chrom-PrepKZR · Traditional | Hamilton Co. | 08/16/1983SE |
| K802725 | Vista 54 Liquid Chromatography Anal. SysKZR · Traditional | Varian Assoc., Inc. | 12/11/1980SE |
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Questions and answers
When was Varian 2000 Liquid Chromatography Analy cleared by the FDA?
Varian 2000 Liquid Chromatography Analy (K841890) received a 510(k) decision of Substantially Equivalent on June 14, 1984, 38 days after the submission was received.
What is the product code of K841890?
The FDA product code is KZR – Chromatography (Liquid, Gel), Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2260.