Product Code: LDM FDA class 1 21 CFR 862.2260

Instrumentation, High Pressure Liquid Chromatography

Clinical Chemistry

High pressure liquid chromatography instrumentation for clinical use is a laboratory instrument platform used in clinical chemistry to separate, identify, and quantify analytes in patient specimens with high resolution and sensitivity, supporting a wide range of diagnostic assays. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls with no premarket notification needed. The product code is LDM, regulated under 21 CFR 862.2260, in the Clinical Chemistry specialty. No special risk flags apply.

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Basic Information

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

Device Characteristics

✗

GMP Exempt

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Implant

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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 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K960392	CDM	Jul 08, 1996	Substantially Equivalent	Bio-Rad
K961557	ALLIANCE 2690 SEPARATIONS MODULE	Jul 05, 1996	Substantially Equivalent	Waters Corporation
K942451	BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM	Nov 10, 1994	Substantially Equivalent	Bio-Rad
K922388	WATERS(TM) LC MODULE I FOR CLINICAL USE	Sep 11, 1992	Substantially Equivalent	Millipore Corp.
K920136	WATERS 717 AUTOSAMPLER	Feb 19, 1992	Substantially Equivalent	Millipore Corp.
K903647	MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE	Sep 11, 1990	Substantially Equivalent	Millipore Corp.
K884886	MODEL 250 LIQUID CHROMOTAGRAPHY PUMP	Feb 02, 1989	Substantially Equivalent	The Perkin-Elmer Corp.
K872582	HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM	Jul 16, 1987	Substantially Equivalent	Millipore Corp.
K870949	WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM	Apr 22, 1987	Substantially Equivalent	Millipore Corp.
K862178	ISOPURE LC SYSTEM	Jul 14, 1986	Substantially Equivalent	The Perkin-Elmer Corp.
K850272	WATERS 740 DATA MODULE-PLOTTER INTEGRATOR	Mar 06, 1985	Substantially Equivalent	Millipore Corp.
K850359	WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D	Mar 05, 1985	Substantially Equivalent	Millipore Corp.
K833113	REPORTING INTEGRATOR 3392A	Nov 21, 1983	Substantially Equivalent	Hewlett-Packard Co.
K832375	LIQUID CHROMATOGRAPH 1090 SERIES	Oct 14, 1983	Substantially Equivalent	Hewlett-Packard Co.
K821727	SERIES 10 LIQUID CHROMOTOGRAPH	Jun 22, 1982	Substantially Equivalent	The Perkin-Elmer Corp.
K821219	SERIES 4 LIQUID CHROMATOGRAPH	May 28, 1982	Substantially Equivalent	The Perkin-Elmer Corp.
K810304	MODEL LC-85 UV DETECTOR	Feb 25, 1981	Substantially Equivalent	The Perkin-Elmer Corp.
K802031	3390A REPORTING INTEGRATOR	Sep 16, 1980	Substantially Equivalent	Hewlett-Packard Co.
K780933	PREP I AUTOMATED SAMPLE PROCESSOR	Jul 27, 1978	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.