Varian 2000 Liquid Chromatography Analy

FDA 510(k) K841890 · Varian Assoc., Inc.

Substantially Equivalent

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)

Official FDA 510(k) record

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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K905538Columns Liquid Chromatography DPMKZR · Traditional Millpore Corp.01/25/1991SE
K861392Syva Solid Phase Columns System IIKZR · Traditional Syva Co.06/13/1986SE
K860197Series 410 LC PumpKZR · Traditional The Perkin-Elmer Corp.03/17/1986SE
K851945Varian Aasp Automated Sample Prep. SystemKZR · Traditional Varian Assoc., Inc.05/24/1985SE
K843568Liquid Chromatograph 400KZR · Traditional The Perkin-Elmer Corp.11/20/1984SE
K840977Liquid Chromatographic Detector LC-95KZR · Traditional The Perkin-Elmer Corp.04/19/1984SE
K832201Chrom-PrepKZR · Traditional Hamilton Co.08/16/1983SE
K802725Vista 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.