442765 Albumin Reagent (ALB 2 x 300)

Reg #: 2050010 · FEI: 2050010 · Expires 2025

View on FDA

Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: BECKMAN COULTER, INC.
Registration Number: 2050010
FEI Number: 2050010
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: 2470 Faraday Ave
City: CARLSBAD
State: CA
ZIP: 92010
Country: US

Regulatory Submissions

510(k) Number: K011465

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
Biuret (Colorimetric), Total Protein	CEK	Class 2	Clinical Chemistry	No	2012-10-31
Enzyme Immunoassay, Propoxyphene	JXN	Class 2	Clinical Toxicology	No	2012-10-31
Prealbumin, Antigen, Antiserum, Control	JZJ	Class 1	Immunology	No	2012-10-31
Hexokinase, Glucose	CFR	Class 2	Clinical Chemistry	No	2012-10-31
Enzyme Immunoassay, Cannabinoids	LDJ	Class 2	Clinical Toxicology	No	2012-10-31
Enzyme Immunoassay, Barbiturate	DIS	Class 2	Clinical Toxicology	No	2012-10-31
Enzyme Immunoassay, Gentamicin	LCD	Class 2	Clinical Toxicology	No	2012-10-31
Colorimetry, Acetaminophen	LDP	Class 2	Clinical Toxicology	No	2012-10-31
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	Class 1	Clinical Chemistry	No	2012-10-31
Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	DMT	Class 2	Clinical Toxicology	No	2012-10-31
Bromcresol Purple Dye-Binding, Albumin	CJW	Class 2	Clinical Chemistry	No	2012-10-31
Enzyme Immunoassay, Phenobarbital	DLZ	Class 2	Clinical Toxicology	No	2012-10-31
Enzyme Immunoassay, Carbamazepine	KLT	Class 2	Clinical Toxicology	No	2012-10-31
Urease And Glutamic Dehydrogenase, Urea Nitrogen	CDQ	Class 2	Clinical Chemistry	No	2012-10-31
Enzyme Immunoassay, Amphetamine	DKZ	Class 2	Clinical Toxicology	No	2012-10-31
Enzyme Immunoassay, Diphenylhydantoin	DIP	Class 2	Clinical Toxicology	No	2012-10-31
Radioassay, Triiodothyronine Uptake	KHQ	Class 2	Clinical Chemistry	No	2012-10-31
Electrode, Ion Specific, Potassium	CEM	Class 2	Clinical Chemistry	No	2012-10-31
Electrode, Ion Specific, Calcium	JFP	Class 2	Clinical Chemistry	No	2012-10-31
Igm, Antigen, Antiserum, Control	DFT	Class 2	Immunology	No	2012-10-31
Colorimetry, Salicylate	DKJ	Class 2	Clinical Toxicology	No	2012-10-31
System, Test, Rheumatoid Factor	DHR	Class 2	Immunology	No	2012-10-31
Electrode, Ion Specific, Sodium	JGS	Class 2	Clinical Chemistry	No	2012-10-31
Enzymatic Method, Bilirubin	JFM	Class 2	Clinical Chemistry	No	2012-10-31
Electrode, Ion-Specific, Chloride	CGZ	Class 2	Clinical Chemistry	No	2012-10-31
Enzyme Immunoassay, Valproic Acid	LEG	Class 2	Clinical Toxicology	No	2012-10-31
Azo Dye, Calcium	CJY	Class 2	Clinical Chemistry	No	2012-10-31
Igg, Antigen, Antiserum, Control	DEW	Class 2	Immunology	No	2012-10-31
Enzyme Immunoassay, Digoxin	KXT	Class 2	Clinical Toxicology	No	2012-10-31
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	CGS	Class 2	Clinical Chemistry	No	2012-10-31
Glucose Oxidase, Glucose	CGA	Class 2	Clinical Chemistry	No	2012-10-31
Enzymatic Esterase--Oxidase, Cholesterol	CHH	Class 1	Clinical Chemistry	No	2012-10-31
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	CDT	Class 1	Clinical Chemistry	No	2012-10-31
Catalytic Methods, Amylase	JFJ	Class 2	Clinical Chemistry	No	2012-10-31
Antistreptolysin - Titer/Streptolysin O Reagent	GTQ	Class 1	Microbiology	No	2012-10-31
Titrimetric With Edta And Indicator, Calcium	CHW	Class 2	Clinical Chemistry	No	2012-10-31
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	CFJ	Class 2	Clinical Chemistry	No	2012-10-31
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	Class 2	Clinical Toxicology	No	2012-10-31
Enzyme Immunoassay, Benzodiazepine	JXM	Class 2	Clinical Toxicology	No	2012-10-31
Lipase-Esterase, Enzymatic, Photometric, Lipase	CHI	Class 1	Clinical Chemistry	No	2012-10-31
Radioimmunoassay, Methaqualone	KXS	Class 2	Clinical Toxicology	No	2012-10-31
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	Class 2	Immunology	No	2012-10-31
Ph Rate Measurement, Carbon-Dioxide	JFL	Class 2	Clinical Chemistry	No	2012-10-31
Transferrin, Antigen, Antiserum, Control	DDG	Class 2	Immunology	No	2012-10-31
Enzyme Immunoassay, Methadone	DJR	Class 2	Clinical Toxicology	No	2012-10-31
Alkaline Picrate, Colorimetry, Creatinine	CGX	Class 2	Clinical Chemistry	No	2012-10-31
Iga, Antigen, Antiserum, Control	CZP	Class 2	Immunology	No	2012-10-31
Hexane Extraction, Fluorescence, Vitamin E	JOB	Class 1	Clinical Chemistry	No	2012-10-31
Enzyme Immunoassay, Opiates	DJG	Class 2	Clinical Toxicology	No	2012-10-31
Enzyme Immunoassay, Theophylline	KLS	Class 2	Clinical Toxicology	No	2012-10-31
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	CJE	Class 2	Clinical Chemistry	No	2012-10-31
Diazo Colorimetry, Bilirubin	CIG	Class 2	Clinical Chemistry	No	2012-10-31
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	Class 1	Clinical Chemistry	No	2012-10-31
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	Class 2	Clinical Chemistry	No	2012-10-31
Fluorescent Immunoassay, Tobramycin	LCR	Class 2	Clinical Toxicology	No	2012-10-31
Albumin, Antigen, Antiserum, Control	DCF	Class 2	Immunology	No	2012-10-31
Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control	DDT	Class 2	Immunology	No	2012-10-31
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	Class 2	Clinical Chemistry	No	2012-10-31
Enzyme Immunoassay, Phencyclidine	LCM	Class U	Unknown	No	2012-10-31
Nadh Oxidation/Nad Reduction, Alt/Sgpt	CKA	Class 1	Clinical Chemistry	No	2012-10-31
U.V. Method, Cpk Isoenzymes	JHW	Class 2	Clinical Chemistry	No	2012-10-31
L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase	JGG	Class 1	Clinical Chemistry	No	2012-10-31
Assay, Glycosylated Hemoglobin	LCP	Class 2	Hematology	No	2012-10-31

Proprietary Names

442765 Albumin Reagent (ALB 2 x 300) 475106 Prealbumin Reagent (PAB 2 x 100) 442820 Urea Reagent (UREA 2 x 300)

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Registrations

Search all FDA establishment registrations in our database.

View all FDA Registrations

Owner / Operator

BECKMAN COULTER, INC.

Search BECKMAN COULTER, INC.

Product Codes

Find other entries with 63 product codes: CEK, JXN, JZJ, CFR, LDJ, DIS, LCD, LDP, JMO, DMT, CJW, DLZ, KLT, CDQ, DKZ, DIP, KHQ, CEM, JFP, DFT, DKJ, DHR, JGS, JFM, CGZ, LEG, CJY, DEW, KXT, CGS, CGA, CHH, CDT, JFJ, GTQ, CHW, CFJ, DIO, JXM, CHI, KXS, DCK, JFL, DDG, DJR, CGX, CZP, JOB, DJG, KLS, CJE, CIG, JJE, CIT, LCR, DCF, DDT, KLI, LCM, CKA, JHW, JGG, LCP

Search CEK

510(k) Number

Find other entries related to 510(k) K011465.

Search K011465