Product Code: KZR FDA class 1 21 CFR 862.2260

Chromatography (Liquid, Gel), Clinical Use

Clinical Chemistry

The Clinical Use Liquid/Gel Chromatography system is a laboratory analytical instrument used in clinical settings to separate, identify, and quantify biological molecules such as proteins, hormones, and drugs from patient samples using a liquid mobile phase passing through a gel or liquid stationary phase. 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 KZR, regulated under 21 CFR 862.2260, in the Clinical Chemistry medical specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: KZR
Device Class: FDA class 1
Regulation Number: 862.2260
Medical Specialty: Clinical Chemistry
Review Panel: TX
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 15 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K973074	2487 DUAL WAVELENGTH ABSORBANCE DETECTOR	Oct 06, 1997	Substantially Equivalent	Waters Corporation
K931227	USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000	May 06, 1993	Substantially Equivalent	U.S. Drug Testing, Inc.
K905538	COLUMNS LIQUID CHROMATOGRAPHY DPM	Jan 25, 1991	Substantially Equivalent	Millpore Corp.
K861392	SYVA SOLID PHASE COLUMNS SYSTEM II	Jun 13, 1986	Substantially Equivalent	Syva Co.
K860197	SERIES 410 LC PUMP	Mar 17, 1986	Substantially Equivalent	The Perkin-Elmer Corp.
K851945	VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM	May 24, 1985	Substantially Equivalent	Varian Assoc., Inc.
K843568	LIQUID CHROMATOGRAPH 400	Nov 20, 1984	Substantially Equivalent	The Perkin-Elmer Corp.
K841890	VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY	Jun 14, 1984	Substantially Equivalent	Varian Assoc., Inc.
K840977	LIQUID CHROMATOGRAPHIC DETECTOR LC-95	Apr 19, 1984	Substantially Equivalent	The Perkin-Elmer Corp.
K832201	CHROM-PREP	Aug 16, 1983	Substantially Equivalent	Hamilton Co.
K802725	VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS	Dec 11, 1980	Substantially Equivalent	Varian Assoc., Inc.
K780945	LIQUID CHROMATOGRAPH MODEL 860	Jul 27, 1978	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K780944	LIQUID CHROMATOGRAPH MODEL 850	Jul 27, 1978	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K770255	LC-65T DETECTOR AND OVEN	Feb 25, 1977	Substantially Equivalent	The Perkin-Elmer Corp.
K770254	CHROMATOGRAPH, SERIES 3, LIQUID	Feb 24, 1977	Substantially Equivalent	The Perkin-Elmer Corp.