Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
FDA product code JJE · 205 cleared devices
Class 1
Clinical Chemistry
- Regulation
- 21 CFR 862.2160
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-12-09 – 2019-02-12
JJE
2019-02-12
JJE
2013-03-22
DIMENSION EXL WITH LM SYSTEM
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JJE
2012-05-17
ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT
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JJE
2011-11-22
DIMENSION CLINICAL CHEMISTRY SYSTEM
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JJE
2011-06-28
INDIKO
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JJE
2008-05-08
TC MATRIX CLINICAL CHEMISTRY ANALYZER
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JJE
2006-11-13
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
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JJE
2005-07-11
DIMENSION VISTA INTEGRATED SYSTEM
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JJE
2005-03-14
STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER
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JJE
2005-02-15
PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240
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JJE
2003-01-28
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
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JJE
2001-08-01
AUTOMATED WORKCELL CONTROL SOFTWARE
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JJE
2000-12-18
MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
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JJE
2000-10-25
OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
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JJE
1998-12-07
BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY
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JJE
1998-02-13
ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER
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JJE
1998-02-12
ABBOTT AXSYM SYSTEM
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JJE
1997-07-22
PERSONALLAB AUTOMATED MICROPLATE ANALYZER
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JJE
1997-04-08
IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER
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JJE
1997-03-10
SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L
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JJE
1997-02-18
STRATEC LIA II ANALYZER
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JJE
1996-12-16
SIGMA DIAGNOSTICS WASH CONCENTRATE
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JJE
1996-08-30
COBAS CORE IMMUNOCHEMISTRY SYSTEM
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JJE
1996-08-02
TECHNICON IMMUNO 1 SYSTEM
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JJE
1996-07-05
OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER
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JJE
1996-06-26
VITROS SPECIALTY DILUENT
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JJE
1996-06-14
ELECSYS 2010 ANALYZER
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JJE
1995-09-25
BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER
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JJE
1995-07-19
SELECTA 20/60 CHEMISTRY ANALYZER
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JJE
1995-06-13
SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0
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JJE
1995-06-09
ABBOTT PROJECT I, SPECTRUM
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JJE
1995-05-16
ABBOTT AXSYM II SYSTEM
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JJE
1995-05-08
SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA)
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JJE
1995-04-20
TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
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JJE
1995-04-20
ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM
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JJE
1995-03-03
MICROPLATE PROCESSOR 3000
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JJE
1995-01-30
DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER
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JJE
1995-01-17
KODAK EKTACCHEM 950IRC ANALYZER
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JJE
1994-11-30
PROCHEM CHEMISTRY ANALYZER
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JJE
1994-11-10
DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM
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JJE
1994-10-04
HITACHI 914 ANALYZER
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JJE
1994-08-26
AURAFLEX SYSTEMS
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JJE
1994-07-18
ABBOTT PRISM ANALYZER
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JJE
1994-05-23
CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF
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JJE
1993-12-10
SIGMA WASH CONCENTRATE SOLUTION
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JJE
1993-10-29
ELS 1000
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JJE
1993-09-21
ACE CLINICAL CHEMISTRY SYSTEM
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JJE
1993-08-31
OLYMPUS REPLY GLUCOSE REAGENT
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JJE
1993-05-12
AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS
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JJE
1993-02-12
SYNCHRON CX5CE CLINICAL ANALYZER
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JJE
1993-02-12
MINIVIDAS INSTRUMENT
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JJE
1992-09-29
ATAC 6000 CHEMISTRY ANALYZER
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JJE
1992-09-15
IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY
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JJE
1992-08-20
DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT
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JJE
1992-07-21
VISTA IMMUNOASSAY SYSTEM -- MODIFICATION
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JJE
1992-07-10
KODAK EKTACHEM 250 ANALYER
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JJE
1992-06-30
BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER
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JJE
1992-06-25
OLYMPUS AU5200 CLINICAL CHEMISTRY ANALYZER
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JJE
1992-04-29
ROCHE COBAS MIRA PLUS
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JJE
1992-03-17
MODEL 560 EXPRESS CLINICAL CHEMISTRY ANALYZER
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JJE
1992-01-28
DIMENSION AR CLINICAL CHEMISTRY SYSTEM
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JJE
1991-09-04
KODAK EKTACHEM DTII SYSTEM
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JJE
1991-07-19
AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)
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JJE
1991-04-03
SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER
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JJE
1990-10-22
SYNCHRON CX 7 CLINICAL ANALYZER
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JJE
1990-10-15
SYNCHRON CX4-CE
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JJE
1990-09-27
KODAK EKTACHEM SOLUTION 7%BSA BOVINE SERUM ALBUMIN
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JJE
1990-07-10
ATAC 6000 CHEMISTRY ANALYZER
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JJE
1990-06-18
CIBA CORNING ACS:180 AUTOMATED CHEMILUMINESCENCE
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JJE
1990-04-16
ES 300 IMMUNOASSAY SYSTEM
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JJE
1990-04-16
BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER
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JJE
1989-10-04
ACCESS CHEMISTRY ANALYZER
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JJE
1989-09-28
TDXR ANALYZER WITH LITES TM LITHIUM CAROUSEL
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JJE
1989-08-10
EXCEL (TM) CHEMISTRY ANALYZER
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JJE
1989-08-03
ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER
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JJE
1989-08-03
CLINIMATE-TDA BLOOD CHEMISTRY ANALYZER
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JJE
1989-03-28
KODAK EKTACHEM 750 SERIES ANALYZER
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JJE
1989-03-28
KODAK EKTACHEM 500 ANALYZER
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JJE
1989-03-28
KODAK EKTACHEM 500/750 SERIES ANALYZER, SOFT V1.0
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JJE
1989-02-27
DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER
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JJE
1989-02-17
TECHNICON AXON(TM) SYSTEM
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JJE
1989-02-07
MODIFIED INTENDED USE OF CLEANING REAGENT KIT
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JJE
1989-02-07
MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL.
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JJE
1989-02-07
KODAK EKTACHEM 700 ANALYZER FAMILY, SOFT V5.0
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JJE
1989-02-07
HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE
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JJE
1988-12-29
SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER
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JJE
1988-12-15
ABC FP ANALYZER
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JJE
1988-10-31
SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER
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JJE
1988-10-25
CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST
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JJE
1988-09-13
TECHNICON RA-100(TM) SYSTEM
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JJE
1988-09-08
OLYMPUS REPLY CHEMISTRY ANALYZER
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JJE
1988-08-30
VISTA INSTRUMENT
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JJE
1988-08-30
DTR ANALYZER
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JJE
1988-08-08
PROFILE ONE OMNI
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JJE
1988-08-04
GEMINII GAMMA COUNTER
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JJE
1988-08-02
D-CHEM
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JJE
1988-07-28
GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.
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JJE
1988-07-01
SPECIFIC CHEMISTRY ANALYZER
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JJE
1988-06-01
SYNCHRON CX(TM)4 CLINICAL ANALYZER
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JJE
1988-06-01
SYNCHRON CX(TM)5 CLINICAL ANALYZER
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