JJE · Class I · 21 CFR 862.2160

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
1–24 of 208
Cleared Feb 12, 2019
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
K183375
Horiba, Ltd.
Chemistry · 68d
Cleared Jan 09, 2014
RX DAYTONA PLUS CHEMISTRY ANALYZER
K131554
Randox Laboratories, Ltd.
Chemistry · 224d
Cleared Mar 22, 2013
DIMENSION EXL WITH LM SYSTEM
K130276
Siemens Healthcare Diagnostics, Inc.
Chemistry · 45d
Cleared Nov 22, 2011
DIMENSION CLINICAL CHEMISTRY SYSTEM
K112999
Siemens Healthcare Diagnostics
Chemistry · 46d
Cleared May 08, 2008
TC MATRIX CLINICAL CHEMISTRY ANALYZER
K073370
Teco Diagnostics
Chemistry · 160d
Cleared Nov 13, 2006
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
K063144
Ortho-Clinical Diagnostics, Inc.
Chemistry · 28d
Cleared Jul 11, 2005
DIMENSION VISTA INTEGRATED SYSTEM
K051087
Dade Behring, Inc.
Chemistry · 74d
Cleared Mar 14, 2005
STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER
K042169
Stanbio Laboratory
Chemistry · 215d
Cleared Jan 28, 2003
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
K023764
Beckman Coulter, Inc.
Chemistry · 77d
Cleared Dec 18, 2000
MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
K003721
Olympus America, Inc.
Chemistry · 14d
Cleared Oct 25, 2000
OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
K002982
Olympus America, Inc.
Chemistry · 30d
Cleared Dec 07, 1998
BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY
K983345
Bayer Corp.
Chemistry · 75d
Cleared Feb 13, 1998
ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER
K974779
Abbott Laboratories
Chemistry · 53d
Cleared Feb 12, 1998
ABBOTT AXSYM SYSTEM
K974651
Abbott Laboratories
Chemistry · 66d
Cleared Mar 10, 1997
SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L
K965240
Beckman Instruments, Inc.
Chemistry · 70d
Cleared Feb 18, 1997
STRATEC LIA II ANALYZER
K961142
Nichols Institute Diagnostics
Hematology · 334d
Cleared Dec 16, 1996
SIGMA DIAGNOSTICS WASH CONCENTRATE
K963539
Sigma Diagnostics, Inc.
Chemistry · 103d
Cleared Aug 30, 1996
COBAS CORE IMMUNOCHEMISTRY SYSTEM
K962231
Roche Diagnostic Systems, Inc.
Chemistry · 81d
Cleared Aug 02, 1996
TECHNICON IMMUNO 1 SYSTEM
K962125
Bayer Corp.
Chemistry · 60d
Cleared Jul 05, 1996
OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER
K961274
Olympus America, Inc.
Chemistry · 94d
Cleared Jun 14, 1996
ELECSYS 2010 ANALYZER
K961481
Boehringer Mannheim Corp.
Chemistry · 57d
Cleared Sep 25, 1995
BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER
K953239
Boehringer Mannheim Corp.
Chemistry · 76d
Cleared Jun 13, 1995
SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0
K951189
Beckman Instruments, Inc.
Chemistry · 89d
Cleared Jun 09, 1995
ABBOTT PROJECT I, SPECTRUM
K945566
Abbott Laboratories
Chemistry · 231d

About Product Code JJE - Regulatory Context