FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K142346 |
Beckman Coulter Ireland Inc. |
Urine/CSF Albumin, Urine/CSF Albumin Calibrator |
10/15/2014 |
K082251 |
BECKMAN COULTER, INC. |
SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 |
04/08/2009 |
K964695 |
BECKMAN INSTRUMENTS, INC. |
IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT |
04/29/1997 |
K972929 |
BEHRING DIAGNOSTICS, INC. |
N ANTISERUM TO HUMAN ALBUMIN |
10/20/1997 |
K033525 |
DADE BEHRING, INC. |
DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114 |
01/12/2004 |
K061990 |
DADE BEHRING, INC. |
DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL |
09/19/2006 |
K051191 |
DIAGNOSTIC CHEMICALS LTD. |
DCL MICROALBUMIN ASSAY, MODEL 252-20 |
07/05/2005 |
K091486 |
KAMIYA BIOMEDICAL CO. |
K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR |
04/29/2010 |
K101089 |
MEDICA CORP. |
EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR |
07/13/2011 |
K042643 |
Ortho-Clinical Diagnostics, Inc. |
VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II |
11/18/2004 |
K053553 |
POLYMEDCO, INC. |
NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL |
03/09/2006 |
K961824 |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN |
07/23/1996 |
K101203 |
Roche Diagnostics |
TINA-QUANT ALBUMIN GEN 2 |
09/10/2010 |
K100853 |
ROCHE DIAGNOSTICS CORP. |
COBAS 8000 MODULAR SERIES ANALYZER |
09/09/2010 |
K113072 |
ROCHE DIAGNOSTICS OPERATIONS |
TINA-QUANT ALBUMIN GEN.2 |
05/14/2012 |
K143118 |
THE BINDING SITE GROUP LTD |
Human Microalbumin kit for use on SPAPLUS |
05/26/2015 |
K153560 |
THE BINDING SITE GROUP LTD |
Optilite Low Level Albumin Kit |
08/25/2016 |
K121045 |
THE BINDING SITE GROUP, LTD. |
HUMAN ALBUMIN CSF KIT |
06/19/2013 |