Product Code: JJG FDA class 1 21 CFR 862.2140

Analyzer, Chemistry, Centrifugal, For Clinical Use

Clinical Chemistry

This device is a centrifugal clinical chemistry analyzer that uses centrifugal force to mix reagents and specimens and perform simultaneous photometric measurements across multiple cuvettes, enabling rapid parallel analysis of patient samples. It is classified as FDA Class 1 and is subject only to general controls, with no premarket notification required. The product code is JJG, regulated under 21 CFR 862.2140, within the Clinical Chemistry medical specialty.

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510(k)s

FEI Numbers

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Basic Information

Product Code: JJG
Device Class: FDA class 1
Regulation Number: 862.2140
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 30 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K972409	AG CHEMISTRY ANALYZER SYSTEM	Aug 28, 1997	Substantially Equivalent	Landmark Scientific, Inc.
K942782	PICCOLO(TM)	Mar 13, 1995	Substantially Equivalent	Abaxis, Inc.
K934592	EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR	Apr 06, 1994	Substantially Equivalent	Abaxis, Inc.
K920942	OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER	Jun 10, 1992	Substantially Equivalent	Olympus Corp.
K910222	COBAS ALPHA	Feb 27, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K903626	BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA	Oct 15, 1990	Substantially Equivalent	Beckman Instruments, Inc.
K893854	COBAS FARA II CENTRIFUGAL ANALYZER	Aug 03, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K893641	COBAS FARA CENTRIFUGAL ANALYZER	Jul 20, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K885203	TECHNICON DAX(TM) SYSTEM	Mar 28, 1989	Substantially Equivalent	Technicon Instruments Corp.
K871973	IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS.	Jun 11, 1987	Substantially Equivalent	Instrumentation Laboratory CO
K871838	BIOMEK 1000C AUTOMATED LABORATORY WORK STATION	May 26, 1987	Substantially Equivalent	Beckman Instruments, Inc.
K854523	ANALYST PHYSICIAN'S OFFICE PROFILER	Jan 08, 1986	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K854055	I.C.L.S. COMPULYZER	Nov 19, 1985	Substantially Equivalent	Integrated Computerized Laboratory Systems, Inc.
K851619	GEN PROFILER SYSTEM	May 14, 1985	Substantially Equivalent	Electro-Cucleonics, Inc.
K843914	COBAS FLUORESCENCE POLARIZATION MODULE	Nov 27, 1984	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K842522	PDA SYSTEM	Aug 02, 1984	Substantially Equivalent	Abbott Laboratories
K840231	DISPOSABLE CUVETTE ARRAY	Mar 22, 1984	Substantially Equivalent	Consumable Lab Supplies
K832716	ENCORE CHEMISTRY ANALYZER	Oct 04, 1983	Substantially Equivalent	Baker Instructions Corp.
K831571	ROTOR	Jun 30, 1983	Substantially Equivalent	American Scientific Products
K831569	REAGENT CUPS	Jun 30, 1983	Substantially Equivalent	American Scientific Products
K830641	ENCORE CHEMISTRY ANALYZER	Apr 05, 1983	Substantially Equivalent	Baker Instructions Corp.
K811525	FLEXIGRAM AUTO LOADER SYSTEM	Jun 18, 1981	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K801139	CENTRIFICHEM SYSTEM 500 ANALYZER	Jun 09, 1980	Substantially Equivalent	Union Carbide Corp.
K801026	IL MODEL 773 FLUORESCENCE LIGHT SCATTER	May 28, 1980	Substantially Equivalent	Instrumentation Laboratory CO
K792671	COBAS-BIO CENTRIFUGAL ANALYZER	Jan 17, 1980	Substantially Equivalent	Hoffmann-La Roche, Inc.
K791180	CENTRIFICHEM SYSTEM 500	Aug 10, 1979	Substantially Equivalent	Union Carbide Corp.
K790550	CENTRIA SYSTEM	May 07, 1979	Substantially Equivalent	Union Carbide Corp.
K790278	ANALYZER, CENTRIFUCHEM SYSTEM 400	Apr 04, 1979	Substantially Equivalent	Union Carbide Corp.
K781900	ANALYZER, AUTOMED CENTRIFUGAL	Dec 20, 1978	Substantially Equivalent	Autogenic Systems
K771813	CENTRIFICHEM SYS 400 ANALYZER	Oct 25, 1977	Substantially Equivalent	Clinical Diagnostics, Inc.