Vista 54 Liquid Chromatography Anal. Sys
FDA 510(k) K802725 · Varian Assoc., Inc.
510(k) numberK802725
Submission
- Device name
- Vista 54 Liquid Chromatography Anal. Sys
- Applicant
- Varian Assoc., Inc.
Mchenry, IL, US - Received
- October 31, 1980
- Decision date
- December 11, 1980
- 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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| K843568 | Liquid Chromatograph 400KZR · Traditional | The Perkin-Elmer Corp. | 11/20/1984SE |
| K841890 | Varian 2000 Liquid Chromatography AnalyKZR · Traditional | Varian Assoc., Inc. | 06/14/1984SE |
| K840977 | Liquid Chromatographic Detector LC-95KZR · Traditional | The Perkin-Elmer Corp. | 04/19/1984SE |
| K832201 | Chrom-PrepKZR · Traditional | Hamilton Co. | 08/16/1983SE |
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Questions and answers
When was Vista 54 Liquid Chromatography Anal. Sys cleared by the FDA?
Vista 54 Liquid Chromatography Anal. Sys (K802725) received a 510(k) decision of Substantially Equivalent on December 11, 1980, 41 days after the submission was received.
What is the product code of K802725?
The FDA product code is KZR – Chromatography (Liquid, Gel), Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2260.