467858 SYNCHRON Systems Albumin Reagent

Reg #: 9680746 · FEI: 1000206808 · Expires 2025

View on FDA

Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: Beckman Coulter Ireland Inc
Registration Number: 9680746
FEI Number: 1000206808
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: LISMEEHAN
City: O CALLAGHANS MILLS Clare
Country: IE

Regulatory Submissions

510(k) Number: K042291

Owner / Operator

Firm Name: BECKMAN COULTER, INC.
Operator Number: 2050012
Address: 250 S. Kraemer Blvd, --
City: Brea
State: CA
Postal Code: 92821
Country: US

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Enzyme Immunoassay, Phenobarbital	DLZ	Class 2	Clinical Toxicology	No	2012-01-05
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	Class 1	Clinical Chemistry	No	2012-01-05
Electrode, Ion Specific, Potassium	CEM	Class 2	Clinical Chemistry	No	2012-01-05
Bromcresol Purple Dye-Binding, Albumin	CJW	Class 2	Clinical Chemistry	No	2012-01-05
Biuret (Colorimetric), Total Protein	CEK	Class 2	Clinical Chemistry	No	2012-01-05
Conductivity Rate, Urea Nitrogen	LFP	Class 2	Clinical Chemistry	No	2012-01-05
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	CFJ	Class 2	Clinical Chemistry	No	2012-01-05
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	Class 1	Clinical Chemistry	No	2012-01-05
Electrode, Ion Specific, Sodium	JGS	Class 2	Clinical Chemistry	No	2012-01-05
Glucose Oxidase, Glucose	CGA	Class 2	Clinical Chemistry	No	2012-01-05
Photometric Method, Iron (Non-Heme)	JIY	Class 1	Clinical Chemistry	No	2012-01-05
Enzyme Immunoassay, Benzodiazepine	JXM	Class 2	Clinical Toxicology	No	2012-01-05
Photometric Method, Magnesium	JGJ	Class 1	Clinical Chemistry	No	2012-01-05
Ph Rate Measurement, Carbon-Dioxide	JFL	Class 2	Clinical Chemistry	No	2012-01-05
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	Class 2	Immunology	No	2012-01-05
Alkaline Picrate, Colorimetry, Creatinine	CGX	Class 2	Clinical Chemistry	No	2012-01-05
Electrode, Ion Specific, Calcium	JFP	Class 2	Clinical Chemistry	No	2012-01-05

Proprietary Names

467858 SYNCHRON Systems Albumin Reagent SYNCHRON Systems Phosphorus Reagent SYNCHRON Systems CO2 Acid Reagent SYNCHRON Systems Urea Nitrogen (BUN) Reagent SYNCHRON Systems Glucose Reagent (Glucose Oxidase) SYNCHRON Systems CO2 Alkaline Buffer Synchron Systems Total Protein Reagent Calcium Electrode UniCel DxC 600 PRO, Recon UniCel DxC 600, Recon UniCel DxC 800 PRO, Recon UniCel DxC 800, Recon Potassium Electrode NA+ Electrode CO2 Electrode Chloride Electrode

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)