FDA 510(k) Applications for Medical Device Product Code "DCF"
(Albumin, Antigen, Antiserum, Control)

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
K780913 BECKMAN INSTRUMENTS, INC. ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM 06/22/1978
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
K900167 BEHRING DIAGNOSTICS, INC. TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT 01/22/1990
K851285 COOPER BIOMEDICAL, INC. RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI 06/17/1985
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
K812496 DAKO CORP. IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALBUM 09/23/1981
K051191 DIAGNOSTIC CHEMICALS LTD. DCL MICROALBUMIN ASSAY, MODEL 252-20 07/05/2005
K953927 INTERNATIONAL ENZYMES, INC. LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM 09/15/1995
K761225 INTL. DIAGNOSTIC TECHNOLOGY LOW LEVEL HUMAN ALBUMIN TEST KITS 04/07/1977
K896059 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. MODIFIED QM300 ALBUMIN ANTIBODY PACK 11/06/1989
K881126 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 ALBUMIN ANTIBODY PACK 04/06/1988
K882082 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 ALBUMIN ANTIBODY PACK 07/08/1988
K881127 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 CALIBRATOR D PACK 04/21/1988
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
K862671 ORION CORP. MICROALBUMINURIA ASSAY 09/18/1986
K802404 ORTHO DIAGNOSTICS, INC. ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE 10/23/1980
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
K771771 STANBIO LABORATORY QUAN. COLOR. DETER. OF SERUM ALBUMIN 10/07/1977
K882153 TECHNICON INSTRUMENTS CORP. TECHNICON DPA-1(TM) SYSTEM 08/04/1988
K895808 TECHNICON INSTRUMENTS CORP. TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN 10/17/1989
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
K914391 THE BINDING SITE, LTD. ALBUMIN TEST RID KIT 12/10/1991
K873862 UNIPATH LTD. ALBUMIN IN SERUM 10/20/1987
K873861 UNIPATH LTD. ALBUMIN IN URINE 10/13/1987
K875161 WAMPOLE LABORATORIES MAT (TM) MICROALBUMIN TEST 02/17/1988


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