ClearanceBrief
Panels › Clinical Chemistry › Product code JJE · Class 1

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Regulation 862.2160

0510(k)s in 12 months (208 all time)
10recalls in 12 months (564 all time)
494recalls that name a 510(k)
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Top companies in JJE

Company510(k)sRecalls
Beckman Coulter, Inc.1146
Ortho-Clinical Diagnostics, Inc.1130
Siemens Healthcare Diagnostics288
Abbott Laboratories1357
Roche Diagnostics Corp.042
Roche Diagnostics Operations, Inc.028
Eastman Kodak Company180
Boehringer Mannheim Corp.160
Abbott Gmbh & Co. KG014
Beckman Instruments, Inc.90
DateFirm and productCodeLinked 510(k)
Aug 22, 2007Dade Behring, Inc.
EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.
Terminated		 JJEK051087
Aug 16, 2007Ortho-Clinical Diagnostics
VITROS 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using VITROS Chemistry Products THC (Cannabinoids) or AMPH (Amphetamine) Reagents, Cat. No. 680 1375.
Terminated		 JJEK031924
K063144
Jun 19, 2007Abbott Laboratories, Inc
ARCHITECT c16000 Processing Module, for in vitro diagnostics; List Number 3L77-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; distributed by Abbott Laboratories, I
Terminated		 JJENone listed
Jun 19, 2007Abbott Laboratories, Inc
ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; distributed by Abbott Laboratories, Ir
Terminated		 JJEK980367
Jun 19, 2007Abbott Laboratories, Inc
ARCHITECT i2000sr Processing Module, for in vitro diagnostics; List Number 3M74-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; distributed by Abbott Laboratories, Irving, TX.
Terminated		 JJEK983212
Jun 19, 2007Abbott Laboratories, Inc
ARCHITECT i2000 Processing Module, for in vitro diagnostics; List Number 8C89-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; distributed by Abbott Laboratories, Irving, TX.
Terminated		 JJEK983212
May 9, 2007Abbott Laboratories, Inc
ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; manufactured by Abbot Laboratories, Irving, TX.
Terminated		 JJEK983212
May 9, 2007Abbott Laboratories, Inc
ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; manufactured by Abbot Laboratories, Irving, TX.
Terminated		 JJEK983212
Mar 22, 2007Siemens Healthcare Diagnostics
ADVIA Centaur CP System, Catalog/Part Number 086-A001. Automated Immunoassay Analyzer. --- Classification of the Device: Under 21 CFR, Part 862.2160, the ADVIA Centaur CP is a discrete photometric c
Terminated		 JJEK971418
Feb 7, 2007Abbott Laboratories, Inc
ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX.
Terminated		 JJEK983212
Feb 7, 2007Abbott Laboratories, Inc
ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX.
Terminated		 JJEK983212
Nov 17, 2006Abbott Diagnostic International, Ltd.
Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100
Terminated		 JJEK041811
K974651
Sep 23, 2006Beckman Coulter Inc
UniCel Dxl 800 Access Immunoassay Systems Wash Buffer, Part Number 8547197 Wash Buffer
Terminated		 JJEK023764
Sep 23, 2006Siemens Healthcare Diagnostics
ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001.
Terminated		 JJEK971418
May 25, 2006Beckman Coulter Inc
Unicel DxC 600/800 SYNCHRON Clinical Systems; Operating Software Version 1.0 and 1.2; Part Number: A20463 and A27331
Terminated		 JJEK042291
May 25, 2006Beckman Coulter Inc
SYNCHRON LX i 725 Clinical Systems; Operating Software Version 4.5; Part Number: A23724
Terminated		 JJEK023049
May 25, 2006Beckman Coulter Inc
SYNCHRON LX 20, SYNCHRON LX 20 PROClinical Systems; Operating Software Version 4.5; Part Number: A23724 In vitro diagnostic.
Terminated		 JJEK011213
Mar 3, 2006Beckman Coulter Inc
UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier
Terminated		 JJEK023764
Jan 18, 2006Abbott Laboratories, Inc
ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, distributed by Abbot Laboratories, Irving, TX.
Terminated		 JJEK980367
Oct 6, 2005Abbott Laboratories, Inc
ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) f
Terminated		 JJEK980367
Oct 6, 2005Beckman Coulter Inc
Synchron LX Systems Version 4.5 Operating Software
Terminated		 JJEK011213
K023049 +1
Oct 6, 2005Abbott Laboratories, Inc
ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Terminated		 JJEK980367
Jul 16, 2005DPC Cirrus
IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836
Terminated		 JJEK970227
Dec 28, 2004Dade Behring , Inc.
StreamLab Analytical Workcell. General Purpose Laboratory Device.
Terminated		 JJENone listed
Dec 28, 2004Beckman Coulter Inc
UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels).
Terminated		 JJEK023764
Oct 9, 2004Abbott Laboratories, Inc
AEROSET Analyzer, Systems Operation Manual.
Terminated		 JJEK980367
Sep 18, 2004Abbott Laboratories HPD/ADD/GPRD
XSYSTEMS Dilution Buffer, list number 9519-02; for In Vitro diagnostic use, Bovine gamma globulin in Phosphate buffer, with Sodium Azide as a preservative; 950 mL bottle, 4 bottles per carton; Abbott
Terminated		 JJENone listed
Sep 2, 2004Roche Diagnostics Corp.
Roche/Hitachi 747 - 200 clinical chemistry analyzer; catalog number 04009223680.
Terminated		 JJEK901003
Sep 2, 2004Roche Diagnostics Corp.
Roche/Hitachi Modular Additional D Module DAT clinical chemistry analyzer; catalog number 04429389160.
Terminated		 JJEK953239
Sep 2, 2004Roche Diagnostics Corp.
Roche/Hitachi Modular Analytical D Module DAT clinical chemistry analyzer; catalog number 04429338160.
Terminated		 JJEK953239
Sep 2, 2004Roche Diagnostics Corp.
Roche/Hitachi Modular Analytical D Module clinical chemistry analyzer; catalog number 03739023001.
Terminated		 JJEK953239
Sep 2, 2004Roche Diagnostics Corp.
Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680.
Terminated		 JJEK901003
Jul 20, 2004Beckman Coulter Inc
UniCel Dxl 800 Access Immunoassay System, P/N 973100.
Terminated		 JJEK023764
Jul 20, 2004Abbott Laboratories, Inc
AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Division, Irving, Texas
Terminated		 JJEK980367
Jul 20, 2004Abbott Laboratories, Inc
ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT c8000 Processing Module. The product is manufactured and distributed by Abbott
Terminated		 JJEK980367
K983212
Jul 20, 2004Roche Diagnostics Corp.
Roche brand OMNI 9 Analyzer; catalog numbers GD0475, GD0475R and GD047591.
Terminated		 JJEK945915
K954018 +2
Jul 20, 2004Roche Diagnostics Corp.
Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and GD0455R.
Terminated		 JJEK945915
K954018 +2
Jul 20, 2004Roche Diagnostics Corp.
Roche brand OMNI 7 Analyzer; catalog numbers GD0435 and GD0435R.
Terminated		 JJEK945915
K954018 +2
Jul 20, 2004Roche Diagnostics Corp.
Roche brand OMNI 6 Analyzer; catalog numbers GD0415, GD0415R and GD041591.
Terminated		 JJEK945915
K954018
Jul 20, 2004Roche Diagnostics Corp.
Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R.
Terminated		 JJEK945915
K954018
Jul 20, 2004Roche Diagnostics Corp.
Roche brand OMNI 4 Analyzer; catalog numbers GD0375 and GD0375R .
Terminated		 JJEK945915
K954018
Jul 20, 2004Roche Diagnostics Corp.
Roche brand OMNI 3 Analyzer; catalog numbers GD0355, GD0355R and GD035591.
Terminated		 JJEK945915
K954018
Jul 20, 2004Roche Diagnostics Corp.
Roche brand OMNI 2 Analyzer; catalog numbers GD0335 and GD0335R.
Terminated		 JJEK945915
K954018
Jul 20, 2004Roche Diagnostics Corp.
Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and GD0315R.
Terminated		 JJEK945915
Jul 20, 2004Abbott Laboratories, Inc
ARCHITECT Processing Module, manufactured by Abbott Laboratories, Irving, Texas
Terminated		 JJEK983212
Jul 20, 2004Abbott Laboratories, Inc
AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Texas
Terminated		 JJEK974651
Jan 10, 2004Roche Diagnostics Corp.
Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591.
Terminated		 JJEK972733
Jan 10, 2004Roche Diagnostics Corp.
Roche brand OMNI 8 clinical chemistry analyzer; catalog numbers GD0455 and GD0455R.
Terminated		 JJEK972733
Jan 10, 2004Roche Diagnostics Corp.
Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R.
Terminated		 JJEK972733
Dec 25, 2003Abbott Laboratories, Inc
The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
Terminated		 JJEK974651

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