Product Code: KIE FDA class 1 21 CFR 862.2260

Apparatus, High Pressure Liquid Chromatography

Clinical Chemistry

High Pressure Liquid Chromatography Apparatus is a laboratory instrument used in clinical chemistry to separate, identify, and quantify chemical compounds in biological specimens by forcing a liquid sample under high pressure through a column packed with a stationary phase, enabling precise analysis of drugs, metabolites, vitamins, and other analytes. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KIE, regulated under 21 CFR 862.2260, within the Clinical Chemistry medical specialty.

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FEI Numbers

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Basic Information

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

Device Characteristics

✗

GMP Exempt

✗

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 25 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K964588	WATERS 515 HPLC PUMP (515)	Nov 29, 1996	Substantially Equivalent	Waters Corporation
K935666	PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP	Apr 26, 1994	Substantially Equivalent	The Perkin-Elmer Corp.
K924347	WATERS(TM) 996 PDA	Dec 11, 1992	Substantially Equivalent	Millipore Corp.
K914841	CHROMATOGRAPHY CLINICAL USE 75JQR	Dec 10, 1991	Substantially Equivalent	Millipore Corp.
K911299	EQUIPMENT/MATERIAL DECONTAMINATING KIT	Apr 08, 1991	Substantially Equivalent	Rohm and Haas Co.
K862506	THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR	Jul 29, 1986	Substantially Equivalent	Millipore Corp.
K844947	EMIT ANCILLARY REAGENTS	Jun 28, 1985	Substantially Equivalent	Syva Co.
K844949	SYVA SAMPLE SEAL	Feb 15, 1985	Substantially Equivalent	Syva Co.
K800556	DIFFERENTIAL REFRACTIVE INDEX DETECTOR	Mar 25, 1980	Substantially Equivalent	Hewlett-Packard Co.
K800516	DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM.	Mar 19, 1980	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K800289	LDC SPECTROMONITOR III	Feb 26, 1980	Substantially Equivalent	Laboratory Data Control
K800046	LDC CHROMATOGRAPHY ACCESSORY MODULE B	Feb 25, 1980	Substantially Equivalent	Laboratory Data Control
K800048	LDC CONSTAMETRIC III HIGHT PRESS. SOL.	Jan 29, 1980	Substantially Equivalent	Laboratory Data Control
K800047	LDC UVIII FIXED WAVELENGTH ULTRAVIOLET	Jan 21, 1980	Substantially Equivalent	Laboratory Data Control
K791661	SYSTEM CONTROLLER 720 SERIES	Sep 24, 1979	Substantially Equivalent	Waters Assoc., Inc.
K790145	SOLVENT DELIVERY SYSTEM	Feb 15, 1979	Substantially Equivalent	Waters Assoc., Inc.
K782175	CARTRIDGE HOLDER, RCM 100	Feb 15, 1979	Substantially Equivalent	Waters Assoc., Inc.
K781915	DATA MODULE	Jan 10, 1979	Substantially Equivalent	Waters Assoc., Inc.
K781771	DETECTOR, MODEL 79875A, VARIABLE	Dec 20, 1978	Substantially Equivalent	Hewlett-Packard Co.
K781379	MODEL 5000, LIQUID CHROMATOGRAPHY	Sep 14, 1978	Substantially Equivalent	Varian Assoc., Inc.
K772364	AUTO. SAMPLING SYSTEM	Jan 05, 1978	Substantially Equivalent	Hewlett-Packard Co.
K771156	MONITOR, LIQ. CHROMATOGRAPHY LC-15 UV	Aug 02, 1977	Substantially Equivalent	The Perkin-Elmer Corp.
K770638	DETECTOR, UV, MOLEL GC-55	Jun 24, 1977	Substantially Equivalent	Peokin-Elmer Corp.
K761351	L080 SERIES LIQUID CHROMATOGRAPH	Feb 02, 1977	Substantially Equivalent	Hewlett-Packard Co.
K761219	SERIES II LIQUID CHROMATOGRAPH	Feb 01, 1977	Substantially Equivalent	The Perkin-Elmer Corp.