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Company · US

Bayer Healthcare, LLC (Diagnostics Division)

FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2004. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)

11recalls (0 in 12 months)

11recalls that name a 510(k)

Product codes

Code	Device	Records
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	4
JGS	Electrode, Ion Specific, Sodium	3
LEG	Enzyme Immunoassay, Valproic Acid	3
CGA	Glucose Oxidase, Glucose	1
GKL	Counter, Cell, Automated (Particle Counter)	1
JIT	Calibrator, Secondary	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Sep 29, 2004	K042015	ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE Bayer Healthcare, Diagnostics Division	CGA
Jan 8, 2004	K033643	CO2 CALIBRATOR/DILUENT Bayer Healthcare, Diagnostics Division	JIT

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Jan 17, 2007	Bayer Healthcare, LLC (Diagnostics Division) ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correctio Terminated	LEG	K990346
Jan 17, 2007	Bayer Healthcare, LLC (Diagnostics Division) ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correct Terminated	LEG	K990346
Jan 17, 2007	Bayer Healthcare, LLC (Diagnostics Division) ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correctio Terminated	LEG	K990346
Aug 29, 2006	Bayer Healthcare, LLC (Diagnostics Division) Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. Terminated	JGS	K990346
Aug 29, 2006	Bayer Healthcare, LLC (Diagnostics Division) ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. Terminated	JGS	K990346
Aug 29, 2006	Bayer Healthcare, LLC (Diagnostics Division) ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. Terminated	JGS	K990346
Aug 4, 2006	Bayer Healthcare, LLC (Diagnostics Division) ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter Terminated	GKL	K971998
Mar 29, 2006	Bayer Healthcare, LLC (Diagnostics Division) Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test sy Terminated	CHL	K031560
Mar 29, 2006	Bayer Healthcare, LLC (Diagnostics Division) Brand Name: RapidLab 1200 System, Model 1260, Part Number 05062460; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test sy Terminated	CHL	K031560
Mar 29, 2006	Bayer Healthcare, LLC (Diagnostics Division) Brand Name: RapidLab 1200 System, Model 1245, Part Number 05061537; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test sys Terminated	CHL	K031560
Mar 29, 2006	Bayer Healthcare, LLC (Diagnostics Division) Brand Name: RapidLab 1200 System, Model 1240, Part Number 05060298; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test sys Terminated	CHL	K031560

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