FDA Product Code JJE: Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Leading manufacturers include Eastman Kodak Company, Boehringer Mannheim Corp. and Abbott Laboratories.
208
Total
208
Cleared
71d
Avg days
1976
Since
FDA 510(k) Cleared Analyzer, Chemistry (photometric, Discrete), For Clinical Use Devices (Product Code JJE)
208 devices
Cleared
Feb 12, 2019
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
Horiba, Ltd.
Chemistry
68d
Cleared
May 16, 2014
CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER
Carolina Liquid Chemistries Corp.
Chemistry
182d
Cleared
May 15, 2014
XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
Jas Diagnostics, Inc.
Chemistry
408d
Cleared
Jan 09, 2014
RX DAYTONA PLUS CHEMISTRY ANALYZER
Randox Laboratories, Ltd.
Chemistry
224d
Cleared
Mar 22, 2013
DIMENSION EXL WITH LM SYSTEM
Siemens Healthcare Diagnostics, Inc.
Chemistry
45d
Cleared
May 17, 2012
ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry
197d
Cleared
Nov 22, 2011
DIMENSION CLINICAL CHEMISTRY SYSTEM
Siemens Healthcare Diagnostics
Chemistry
46d
Cleared
Jun 28, 2011
INDIKO
Thermofisher Scientific OY
Chemistry
174d
Cleared
May 08, 2008
TC MATRIX CLINICAL CHEMISTRY ANALYZER
Teco Diagnostics
Chemistry
160d
Cleared
Nov 13, 2006
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
Ortho-Clinical Diagnostics, Inc.
Chemistry
28d
Cleared
Jul 11, 2005
DIMENSION VISTA INTEGRATED SYSTEM
Dade Behring, Inc.
Chemistry
74d
Cleared
Mar 14, 2005
STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER
Stanbio Laboratory
Chemistry
215d
Cleared
Jan 28, 2003
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
Beckman Coulter, Inc.
Chemistry
77d
Cleared
Dec 18, 2000
MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
Olympus America, Inc.
Chemistry
14d
Cleared
Oct 25, 2000
OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
Olympus America, Inc.
Chemistry
30d
Cleared
Dec 07, 1998
BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY
Bayer Corp.
Chemistry
75d
Cleared
Feb 13, 1998
ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER
Abbott Laboratories
Chemistry
53d
Cleared
Feb 12, 1998
ABBOTT AXSYM SYSTEM
Abbott Laboratories
Chemistry
66d
Cleared
Jul 22, 1997
PERSONALLAB AUTOMATED MICROPLATE ANALYZER
Biochem Immunosystems (U.S.), Inc.
Chemistry
71d
Cleared
Apr 08, 1997
IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER
Dpc Cirrus
Microbiology
81d
Cleared
Mar 10, 1997
SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L
Beckman Instruments, Inc.
Chemistry
70d
Cleared
Feb 18, 1997
STRATEC LIA II ANALYZER
Nichols Institute Diagnostics
Hematology
334d
Cleared
Dec 16, 1996
SIGMA DIAGNOSTICS WASH CONCENTRATE
Sigma Diagnostics, Inc.
Chemistry
103d
Cleared
Aug 30, 1996
COBAS CORE IMMUNOCHEMISTRY SYSTEM
Roche Diagnostic Systems, Inc.
Chemistry
81d