FDA 510(k) Applications Submitted by ANNETTE HELLIE

FDA 510(k) Number Submission Date Device Name Applicant
K000121 01/18/2000 IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB BECKMAN COULTER, INC.
K060130 01/18/2006 IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT BECKMAN COULTER, INC.
K010236 01/25/2001 IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT BECKMAN COULTER, INC.
K010358 02/06/2001 VIGIL SEROLOGY CONTROL LEVEL C BECKMAN COULTER, INC.
K010597 02/28/2001 SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT BECKMAN COULTER, INC.
K990704 03/04/1999 ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT BECKMAN COULTER, INC.
K040767 03/25/2004 SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT BECKMAN COULTER, INC.
K140829 04/01/2014 UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT BECKMAN COULTER, INC.
K060935 04/05/2006 SYNCHRON SYSTEMS CREATININE (CREA) REAGENT BECKMAN COULTER, INC.
K981403 04/17/1998 IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT BECKMAN INSTRUMENTS, INC.
K011213 04/20/2001 MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM BECKMAN COULTER, INC.
K971602 05/01/1997 ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT BECKMAN INSTRUMENTS, INC.
K981638 05/08/1998 IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT BECKMAN COULTER, INC.
K971788 05/14/1997 SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR BECKMAN INSTRUMENTS, INC.
K051307 05/19/2005 SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT BECKMAN COULTER, INC.
K121492 05/21/2012 UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT BECKMAN COULTER, INC.
K963048 08/06/1996 IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT BECKMAN INSTRUMENTS, INC.
K963061 08/07/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT BECKMAN INSTRUMENTS, INC.
K002799 09/08/2000 PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 BECKMAN COULTER, INC.
K963673 09/13/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS BECKMAN INSTRUMENTS, INC.
K023048 09/13/2002 MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT BECKMAN COULTER, INC.
K963868 09/26/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) BECKMAN INSTRUMENTS, INC.
K963974 10/02/1996 IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN BECKMAN INSTRUMENTS, INC.
K963976 10/04/1996 IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT BECKMAN INSTRUMENTS, INC.
K964009 10/07/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS BECKMAN INSTRUMENTS, INC.
K973813 10/07/1997 IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT BECKMAN INSTRUMENTS, INC.
K973928 10/15/1997 BECKMAN URINE PROTEIN CALIBRATOR (UCAL) BECKMAN INSTRUMENTS, INC.
K973932 10/15/1997 BECKMAN CALIBRATOR 2 (CAL2) BECKMAN INSTRUMENTS, INC.
K974050 10/24/1997 SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT BECKMAN INSTRUMENTS, INC.
K964260 10/25/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG BECKMAN INSTRUMENTS, INC.
K964257 10/25/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT BECKMAN INSTRUMENTS, INC.
K974110 10/31/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT BECKMAN INSTRUMENTS, INC.
K964762 11/27/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT BECKMAN INSTRUMENTS, INC.
K964766 11/27/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) BECKMAN INSTRUMENTS, INC.
K964843 12/03/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT BECKMAN INSTRUMENTS, INC.
K974564 12/05/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT BECKMAN INSTRUMENTS, INC.
K014034 12/07/2001 MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) BECKMAN COULTER, INC.
K965033 12/17/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT BECKMAN INSTRUMENTS, INC.
K965035 12/17/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT BECKMAN INSTRUMENTS, INC.
K024210 12/20/2002 IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR BECKMAN COULTER, INC.
K043556 12/27/2004 SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT BECKMAN COULTER, INC.


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