ClearanceBrief
Panels › Immunology › Product code DCF · Class 2

Albumin, Antigen, Antiserum, Control

Regulation 866.5040

0510(k)s in 12 months (37 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
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Top companies in DCF

Company510(k)sRecalls
Kallestad Diag, A Div. of Erbamont, Inc.40
The Binding Site Group , Ltd.30
Beckman Coulter, Inc.11
Beckman Instruments, Inc.20
Behring Diagnostics, Inc.20
Dade Behring, Inc.20
Ortho-Clinical Diagnostics, Inc.11
Roche Diagnostics20
Technicon Instruments Corp.20
Unipath , Ltd.20
Decided510(k)Device and applicantCode
Aug 25, 2016K153560Optilite Low Level Albumin Kit
The Binding Site Group , Ltd., GB
DCF
May 26, 2015K143118Human Microalbumin kit for use on SPAPLUS
The Binding Site Group , Ltd., GB
DCF
Oct 15, 2014K142346Urine/CSF Albumin, Urine/CSF Albumin Calibrator
Beckman Coulter Ireland, Inc., IE
DCF
Jun 19, 2013K121045HUMAN ALBUMIN CSF KIT
The Binding Site Group , Ltd., GB
DCF
May 14, 2012K113072TINA-QUANT ALBUMIN GEN.2
Roche Diagnostics Operations
DCF
Jul 13, 2011K101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
Medica Corp.
DCF
Sep 10, 2010K101203TINA-QUANT ALBUMIN GEN 2
Roche Diagnostics
DCF
Sep 9, 2010K100853COBAS 8000 MODULAR SERIES ANALYZER
Roche Diagnostics Corp.
DCF
Apr 29, 2010K091486K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR
Kamiya Biomedical Co.
DCF
Apr 8, 2009K082251SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
Beckman Coulter, Inc.
DCF
Sep 19, 2006K061990DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL
Dade Behring, Inc.
DCF
Mar 9, 2006K053553NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL
Polymedco, Inc.
DCF
Jul 5, 2005K051191DCL MICROALBUMIN ASSAY, MODEL 252-20
Diagnostic Chemicals , Ltd., CA
DCF
Nov 18, 2004K042643VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II
Ortho-Clinical Diagnostics, Inc.
DCF
Jan 12, 2004K033525DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114
Dade Behring, Inc.
DCF
Oct 20, 1997K972929N ANTISERUM TO HUMAN ALBUMIN
Behring Diagnostics, Inc.
DCF
Apr 29, 1997K964695IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT
Beckman Instruments, Inc.
DCF
Jul 23, 1996K961824COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
Roche Diagnostic Systems, Inc.
DCF
Sep 15, 1995K953927LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM
International Enzymes, Inc.
DCF
Dec 10, 1991K914391ALBUMIN TEST RID KIT
The Binding Site, Ltd.
DCF
Jan 22, 1990K900167TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT
Behring Diagnostics, Inc.
DCF
Nov 6, 1989K896059MODIFIED QM300 ALBUMIN ANTIBODY PACK
Kallestad Diag, A Div. of Erbamont, Inc.
DCF
Oct 17, 1989K895808TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN
Technicon Instruments Corp.
DCF
Aug 4, 1988K882153TECHNICON DPA-1(TM) SYSTEM
Technicon Instruments Corp.
DCF
Jul 8, 1988K882082QM300 ALBUMIN ANTIBODY PACK
Kallestad Diag, A Div. of Erbamont, Inc.
DCF
Apr 21, 1988K881127QM300 CALIBRATOR D PACK
Kallestad Diag, A Div. of Erbamont, Inc.
DCF
Apr 6, 1988K881126QM300 ALBUMIN ANTIBODY PACK
Kallestad Diag, A Div. of Erbamont, Inc.
DCF
Feb 17, 1988K875161MAT (TM) MICROALBUMIN TEST
Wampole Laboratories
DCF
Oct 20, 1987K873862ALBUMIN IN SERUM
Unipath , Ltd., GB
DCF
Oct 13, 1987K873861ALBUMIN IN URINE
Unipath , Ltd., GB
DCF
Sep 18, 1986K862671MICROALBUMINURIA ASSAY
Orion Corp., FI
DCF
Jun 17, 1985K851285RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI
Cooper Biomedical, Inc.
DCF
Sep 23, 1981K812496IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALBUM
Dako Corp.
DCF
Oct 23, 1980K802404ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE
Ortho Diagnostics, Inc.
DCF
Jun 22, 1978K780913ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM
Beckman Instruments, Inc.
DCF
Oct 7, 1977K771771QUAN. COLOR. DETER. OF SERUM ALBUMIN
Stanbio Laboratory
DCF
Apr 7, 1977K761225LOW LEVEL HUMAN ALBUMIN TEST KITS
Intl. Diagnostic Technology
DCF

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