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

Company	510(k)s	Recalls
Beckman Coulter, Inc.	1	146
Ortho-Clinical Diagnostics, Inc.	1	130
Siemens Healthcare Diagnostics	2	88
Abbott Laboratories	13	57
Roche Diagnostics Corp.	0	42
Roche Diagnostics Operations, Inc.	0	28
Eastman Kodak Company	18	0
Boehringer Mannheim Corp.	16	0
Abbott Gmbh & Co. KG	0	14
Beckman Instruments, Inc.	9	0

Date	Firm and product	Code	Linked 510(k)
Aug 21, 2003	Abbott Laboratories, Inc Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irving, Texas Terminated	JJE	K980367
Aug 20, 2003	DPC Cirrus Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software. Terminated	JJE	None listed
Aug 13, 2003	Abbott Laboratories, Inc ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories, Irving, Texas Terminated	JJE	K983212
Jul 30, 2003	Diametrics Medical, Inc. IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box of IRMA SL Blood Analysis System CC pH, pCO2, pO2, Terminated	JJE	K924758 K945240
May 20, 2003	Abbott Laboratories, Inc AEROSET Analyzer Terminated	JJE	K980367
May 20, 2003	Abbott Laboratories, Inc Aeroset Analyzer, item 9D05-01 Terminated	JJE	K980367
May 9, 2003	Abbott Laboratories, Inc AEROSET System External Waste Pump Terminated	JJE	K980367
May 9, 2003	Abbott Laboratories, Inc ARCHITECT i System External Waste Pump Terminated	JJE	None listed
May 1, 2003	Abbott Laboratories, Inc AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01. Terminated	JJE	K980367
Apr 16, 2003	Abbott Laboratories, Inc AEROSET Software versions 1.00ER005, catalog number 2-89996-01 and 1.00ER005.2, catalog number 2-89996-02 Terminated	JJE	K980367
Apr 15, 2003	Abbott Laboratories, Inc AEROSET System Software version 1.00ER005 Catalog Number 2-89996-01 and 1.00ER005.2 Catalog Number 2-89996-02, distributed by Abbott Laboratories Terminated	JJE	None listed
Mar 6, 2003	Abbott Health Products, Inc. AFP Control Kit distributed under the following label: AxSYM and IMx, Abbott Laboratories USA, North Chicago, IL 60064 Terminated	JJE	None listed
Mar 6, 2003	Beckman Coulter Inc Access and Access 2 Immunoassay Systems 862.2160 Discrete photometric chemistry analyzer for clinical use. Terminated	JJE	K922823
Jan 11, 2003	Abbott Laboratories, Inc AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03 Terminated	JJE	K974651

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