Product Code: JJF FDA class 1 21 CFR 862.2170

Analyzer, Chemistry, Micro, For Clinical Use

Clinical Chemistry

This device is a micro-scale clinical chemistry analyzer designed to perform quantitative biochemical testing on small sample volumes, suitable for applications such as neonatal testing or point-of-care settings where specimen availability is limited. It is classified as FDA Class 1, indicating low risk and requiring only general controls with no premarket notification. The product code is JJF, regulated under 21 CFR 862.2170, and belongs to the Clinical Chemistry medical specialty.

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510(k)s

FEI Numbers

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Unique Applicants

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Basic Information

Product Code: JJF
Device Class: FDA class 1
Regulation Number: 862.2170
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 57 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K052794	ETI-MAX 3000	Mar 31, 2006	Substantially Equivalent	DiaSorin, Inc.
K040332	POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER	Jun 16, 2004	Substantially Equivalent	Arkray, Inc.
K033734	LIGHTCYCLER INSTRUMENT VERSION 1.2	Dec 17, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K013654	PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER	Jun 05, 2002	Substantially Equivalent	Precision Systems, Inc.
K012966	ROCHE COBAS TAQMAN ANALYZER	Feb 01, 2002	Substantially Equivalent	Roche Molecular Systems, Inc.
K993634	CARESIDE ANALYZER	Dec 02, 1999	Substantially Equivalent	Careside, Inc.
K973628	VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA	Mar 13, 1998	Substantially Equivalent	Vital Scientific N.V.
K980056	CARESIDE ANALYZER	Mar 06, 1998	Substantially Equivalent	Exigent Diagnostics, Inc.
K973177	MAGO AUTOMATED EIA PROCESSOR	Oct 09, 1997	Substantially Equivalent	Diamedix Corp.
K971491	SYNERMED IR 200 CHEMISTRY ANALYZER	Jun 26, 1997	Substantially Equivalent	Synermed, Inc.
K964506	ROCHE COBAS AMPLICOR ANALYZER	May 21, 1997	Substantially Equivalent	Roche Molecular Systems, Inc.
K965103	WINMAX SOFTWARE SYSTEMS	May 09, 1997	Substantially Equivalent	Diagnostic Products Corp.
K964409	HCL - 200 BIOCHEMISTRY ANALYZER	Jan 22, 1997	Substantially Equivalent	Hcl Laboratory Systems, Inc.
K961209	BRIO AUTOMATIC SAMPLINC UNIT	Dec 24, 1996	Substantially Equivalent	Seac S.R.L.
K943978	WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS	May 02, 1995	Substantially Equivalent	Waters Chromatography Division
K942676	SYNCHRON CX3 DELTA	Nov 02, 1994	Substantially Equivalent	Beckman-Diagnostic Systems Group
K925093	SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA	Nov 16, 1993	Substantially Equivalent	Beckman Instruments, Inc.
K912055	SYVA EDMS	Jun 10, 1991	Substantially Equivalent	Syva Co.
K903357	SYVA(R) ETS(R) PLUS SYSTEM	Sep 27, 1990	Substantially Equivalent	Syva Co.
K893768	MODIFIED PK300 AUTOMATIC EIA ANALYZER	Aug 15, 1989	Substantially Equivalent	Olympus Corp.
K883350	RECONDITIONED ASTRA(TM) 4	Mar 16, 1989	Substantially Equivalent	Associated Electro-Medical Services, Inc.
K883298	RECONDITIONED ASTRA (TM) 8	Mar 16, 1989	Substantially Equivalent	Associated Electro-Medical Services, Inc.
K883020	RFA-300 RAPID FLOW ANALYZER W/COMPUTER	Sep 02, 1988	Substantially Equivalent	Alpkem Corp.
K872120	SERALYZER III BLOOD CHEMISTRY ANALYZER	Oct 28, 1987	Substantially Equivalent	Miles Laboratories, Inc.
K871486	(FPIA) ASSAY BUFFER	May 08, 1987	Substantially Equivalent	Windsor Laboratories, Inc.
K870777	PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER	Mar 13, 1987	Substantially Equivalent	Kone Instruments, Inc.
K863245	SYVA ETS SYSTEM	Mar 13, 1987	Substantially Equivalent	Syva Co.
K864834	OLYMPUS PK300	Feb 20, 1987	Substantially Equivalent	Olympus Corp.
K864236	SYNCHRON CX3	Dec 31, 1986	Substantially Equivalent	Beckman Instruments, Inc.
K852385	HYBRITECH IMMUNOCHEMISTRY ANALYZER	Jul 12, 1985	Substantially Equivalent	Hybritech, Inc.
K851933	CLINICAL CHEMISTRY ANALYTICAL SYSTEM	Jun 10, 1985	Substantially Equivalent	Allied Instrumentation Laboratory
K851542	RFA-300 RAPID FLOW ANALYZER W/COMPUTER	May 10, 1985	Substantially Equivalent	Alpkem Corp.
K851172	COBAS MIRA	May 02, 1985	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K850999	TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN	Apr 08, 1985	Substantially Equivalent	Technicon Instruments Corp.
K844586	IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS	Dec 11, 1984	Substantially Equivalent	Instrumentation Laboratory CO
K840200	PROGRESS SELECTIVE DHEMISTRY ANALYZ	Apr 04, 1984	Substantially Equivalent	Kone Instruments, Inc.
K833998	QCA CHEMISTRY ANALYZER	Jan 30, 1984	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K833804	SHABAN 9865 IL#78637 JUNCTION BLOC	Jan 13, 1984	Substantially Equivalent	Shaban Mfg. Co.
K833154	NOVA 9 SODIUM/POTASSIUM/TOTAL CALCIUM	Dec 08, 1983	Substantially Equivalent	Nova Biomedical Corp.
K833153	NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU	Nov 25, 1983	Substantially Equivalent	Nova Biomedical Corp.
K831227	COMPUR EASY TOUCH CHEMISTRY ANALYZER-	Jun 02, 1983	Substantially Equivalent	Worthington Diagnostic Systems
K830095	RAPID CHEM ANALYZER II	Jan 28, 1983	Substantially Equivalent	Macomb Chemical Co.
K821583	AMES/GILFORD OPTIMATE CLIN. CHEM & THER	Jun 24, 1982	Substantially Equivalent	Gilford Instrument Laboratories, Inc.
K820541	MICROLYTE	May 24, 1982	Substantially Equivalent	Kone Instruments, Inc.
K820748	POLI-MAK MODEL F-4 (FINAL	Apr 06, 1982	Substantially Equivalent	Pm America, Inc.
K820415	4150 ALPHA AMINO ACID ANALYZER	Mar 11, 1982	Substantially Equivalent	Lkb Instruments, Inc.
K803004	AMINO ACID ANALYSER SYSTEM	Dec 22, 1980	Substantially Equivalent	Lkb Instruments, Inc.
K802398	ELECTROLY TE CHEMISTRY ANALYZER	Oct 31, 1980	Substantially Equivalent	Instrumentation Laboratory CO
K802264	WASH SOLUTION KIT, #88102	Oct 31, 1980	Substantially Equivalent	Hi Chem, Inc.
K802392	ASTRA PRINTER PAPER #88112-CHLORIDE SILV	Oct 23, 1980	Substantially Equivalent	Hi Chem, Inc.
K790197	REAGENT KIT, LANCER GLUCOSE	Mar 12, 1979	Substantially Equivalent	Sherwood Medical Industries
K790335	HYCEL M	Feb 27, 1979	Substantially Equivalent	Hycel, Inc.
K781606	MEPA-1 BLOOD ANALYZER	Oct 03, 1978	Substantially Equivalent	Medico Electronic, Inc.
K781442	BECKMAN ASTRA SYSTEM	Oct 03, 1978	Substantially Equivalent	Beckman Instruments, Inc.
K771821	STAC SYSTEM	Nov 07, 1977	Substantially Equivalent	Technicon Instruments Corp.
K771939	STAC SYSTEM-ADDI. ANALYTES	Nov 03, 1977	Substantially Equivalent	Technicon Instruments Corp.
K771513	KEM-O-MAT	Aug 22, 1977	Substantially Equivalent	Coulter Electronics, Inc.