Analyzer, Chemistry, Micro, For Clinical Use

FDA product code JJF · 57 cleared devices

Class 1 Clinical Chemistry

Regulation: 21 CFR 862.2170
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-08-22 – 2006-03-31

JJF 2006-03-31

ETI-MAX 3000

Applicant DiaSorin, Inc.

K number K052794

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JJF 2004-06-16

POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER

Applicant Arkray, Inc.

K number K040332

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JJF 2003-12-17

LIGHTCYCLER INSTRUMENT VERSION 1.2

Applicant Roche Diagnostics Corp.

K number K033734

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JJF 2002-06-05

PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER

Applicant Precision Systems, Inc.

K number K013654

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JJF 2002-02-01

ROCHE COBAS TAQMAN ANALYZER

Applicant Roche Molecular Systems, Inc.

K number K012966

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JJF 1999-12-02

CARESIDE ANALYZER

Applicant Careside, Inc.

K number K993634

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JJF 1998-03-13

VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA

Applicant Vital Scientific N.V.

K number K973628

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JJF 1998-03-06

CARESIDE ANALYZER

Applicant Exigent Diagnostics, Inc.

K number K980056

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JJF 1997-10-09

MAGO AUTOMATED EIA PROCESSOR

Applicant Diamedix Corp.

K number K973177

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JJF 1997-06-26

SYNERMED IR 200 CHEMISTRY ANALYZER

Applicant Synermed, Inc.

K number K971491

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JJF 1997-05-21

ROCHE COBAS AMPLICOR ANALYZER

Applicant Roche Molecular Systems, Inc.

K number K964506

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JJF 1997-05-09

WINMAX SOFTWARE SYSTEMS

Applicant Diagnostic Products Corp.

K number K965103

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JJF 1997-01-22

HCL - 200 BIOCHEMISTRY ANALYZER

Applicant Hcl Laboratory Systems, Inc.

K number K964409

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JJF 1996-12-24

BRIO AUTOMATIC SAMPLINC UNIT

Applicant Seac S.R.L.

K number K961209

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JJF 1995-05-02

WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS

Applicant Waters Chromatography Division

K number K943978

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JJF 1994-11-02

SYNCHRON CX3 DELTA

Applicant Beckman-Diagnostic Systems Group

K number K942676

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JJF 1993-11-16

SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA

Applicant Beckman Instruments, Inc.

K number K925093

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JJF 1991-06-10

SYVA EDMS

Applicant Syva Co.

K number K912055

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JJF 1990-09-27

SYVA(R) ETS(R) PLUS SYSTEM

Applicant Syva Co.

K number K903357

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JJF 1989-08-15

MODIFIED PK300 AUTOMATIC EIA ANALYZER

Applicant Olympus Corp.

K number K893768

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JJF 1989-03-16

RECONDITIONED ASTRA(TM) 4

Applicant Associated Electro-Medical Services, Inc.

K number K883350

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JJF 1989-03-16

RECONDITIONED ASTRA (TM) 8

Applicant Associated Electro-Medical Services, Inc.

K number K883298

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JJF 1988-09-02

RFA-300 RAPID FLOW ANALYZER W/COMPUTER

Applicant Alpkem Corp.

K number K883020

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JJF 1987-10-28

SERALYZER III BLOOD CHEMISTRY ANALYZER

Applicant Miles Laboratories, Inc.

K number K872120

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JJF 1987-05-08

(FPIA) ASSAY BUFFER

Applicant Windsor Laboratories, Inc.

K number K871486

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JJF 1987-03-13

PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER

Applicant Kone Instruments, Inc.

K number K870777

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JJF 1987-03-13

SYVA ETS SYSTEM

Applicant Syva Co.

K number K863245

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JJF 1987-02-20

OLYMPUS PK300

Applicant Olympus Corp.

K number K864834

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JJF 1986-12-31

SYNCHRON CX3

Applicant Beckman Instruments, Inc.

K number K864236

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JJF 1985-07-12

HYBRITECH IMMUNOCHEMISTRY ANALYZER

Applicant Hybritech, Inc.

K number K852385

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JJF 1985-06-10

CLINICAL CHEMISTRY ANALYTICAL SYSTEM

Applicant Allied Instrumentation Laboratory

K number K851933

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JJF 1985-05-10

RFA-300 RAPID FLOW ANALYZER W/COMPUTER

Applicant Alpkem Corp.

K number K851542

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JJF 1985-05-02

COBAS MIRA

Applicant Roche Diagnostic Systems, Inc.

K number K851172

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JJF 1985-04-08

TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN

Applicant Technicon Instruments Corp.

K number K850999

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JJF 1984-12-11

IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS

Applicant Instrumentation Laboratory CO

K number K844586

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JJF 1984-04-04

PROGRESS SELECTIVE DHEMISTRY ANALYZ

Applicant Kone Instruments, Inc.

K number K840200

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JJF 1984-01-30

QCA CHEMISTRY ANALYZER

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K833998

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JJF 1984-01-13

SHABAN 9865 IL#78637 JUNCTION BLOC

Applicant Shaban Mfg. Co.

K number K833804

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JJF 1983-12-08

NOVA 9 SODIUM/POTASSIUM/TOTAL CALCIUM

Applicant Nova Biomedical Corp.

K number K833154

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JJF 1983-11-25

NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU

Applicant Nova Biomedical Corp.

K number K833153

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JJF 1983-06-02

COMPUR EASY TOUCH CHEMISTRY ANALYZER-

Applicant Worthington Diagnostic Systems

K number K831227

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JJF 1983-01-28

RAPID CHEM ANALYZER II

Applicant Macomb Chemical Co.

K number K830095

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JJF 1982-06-24

AMES/GILFORD OPTIMATE CLIN. CHEM & THER

Applicant Gilford Instrument Laboratories, Inc.

K number K821583

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JJF 1982-05-24

MICROLYTE

Applicant Kone Instruments, Inc.

K number K820541

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JJF 1982-04-06

POLI-MAK MODEL F-4 (FINAL

Applicant Pm America, Inc.

K number K820748

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JJF 1982-03-11

4150 ALPHA AMINO ACID ANALYZER

Applicant Lkb Instruments, Inc.

K number K820415

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JJF 1980-12-22

AMINO ACID ANALYSER SYSTEM

Applicant Lkb Instruments, Inc.

K number K803004

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JJF 1980-10-31

ELECTROLY TE CHEMISTRY ANALYZER

Applicant Instrumentation Laboratory CO

K number K802398

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JJF 1980-10-31

WASH SOLUTION KIT, #88102

Applicant Hi Chem, Inc.

K number K802264

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JJF 1980-10-23

ASTRA PRINTER PAPER #88112-CHLORIDE SILV

Applicant Hi Chem, Inc.

K number K802392

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JJF 1979-03-12

REAGENT KIT, LANCER GLUCOSE

Applicant Sherwood Medical Industries

K number K790197

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JJF 1979-02-27

HYCEL M

Applicant Hycel, Inc.

K number K790335

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JJF 1978-10-03

MEPA-1 BLOOD ANALYZER

Applicant Medico Electronic, Inc.

K number K781606

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JJF 1978-10-03

BECKMAN ASTRA SYSTEM

Applicant Beckman Instruments, Inc.

K number K781442

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JJF 1977-11-07

STAC SYSTEM

Applicant Technicon Instruments Corp.

K number K771821

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JJF 1977-11-03

STAC SYSTEM-ADDI. ANALYTES

Applicant Technicon Instruments Corp.

K number K771939

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JJF 1977-08-22

KEM-O-MAT

Applicant Coulter Electronics, Inc.

K number K771513

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