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 Jul 11, 2005
DIMENSION VISTA INTEGRATED SYSTEM
K051087
Dade Behring, Inc.
Chemistry · 74d
Cleared Jan 28, 2003
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
K023764
Beckman Coulter, Inc.
Chemistry · 77d
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 Aug 30, 1996
COBAS CORE IMMUNOCHEMISTRY SYSTEM
K962231
Roche Diagnostic Systems, Inc.
Chemistry · 81d
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
Cleared May 16, 1995
ABBOTT AXSYM II SYSTEM
K950915
Abbott Laboratories
Toxicology · 76d
Cleared May 08, 1995
SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA)
K950958
Beckman Instruments, Inc.
Chemistry · 82d
Cleared Nov 10, 1994
DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM
K944093
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 80d
Cleared Oct 04, 1994
HITACHI 914 ANALYZER
K942364
Boehringer Mannheim Corp.
Chemistry · 140d
Cleared Dec 10, 1993
SIGMA WASH CONCENTRATE SOLUTION
K933703
Sigma Chemical Co.
Chemistry · 134d
Cleared May 12, 1993
AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS
K930489
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 103d
Cleared Feb 12, 1993
SYNCHRON CX5CE CLINICAL ANALYZER
K926060
Beckman Instruments, Inc.
Chemistry · 73d
Cleared Aug 20, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT
K922680
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 77d
Cleared Jul 21, 1992
VISTA IMMUNOASSAY SYSTEM -- MODIFICATION
K922139
Syva Co.
Chemistry · 96d
Cleared Jul 10, 1992
KODAK EKTACHEM 250 ANALYER
K922072
Eastman Kodak Company
Chemistry · 67d
Cleared Jun 30, 1992
BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER
K921661
Boehringer Mannheim Corp.
Chemistry · 84d
Cleared Apr 29, 1992
ROCHE COBAS MIRA PLUS
K920402
Roche Diagnostic Systems, Inc.
Chemistry · 89d
Cleared Sep 04, 1991
KODAK EKTACHEM DTII SYSTEM
K912844
Eastman Kodak Company
Chemistry · 70d

About Product Code JJE - Regulatory Context