FDA 510(k) Applications Submitted by KATHLEEN DRAY- LYONS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K092283 |
07/29/2009 |
DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K063206 |
10/23/2006 |
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH |
DADE BEHRING, INC. |
| K960257 |
01/18/1996 |
N ANTISERUM TO C1 INHIBITOR |
BEHRING DIAGNOSTICS, INC. |
| K060677 |
03/14/2006 |
N LATEX CDT |
DADE BEHRING, INC. |
| K160724 |
03/16/2016 |
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K181082 |
04/24/2018 |
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) |
Siemens Healthcare Diagnostics, Inc. |
| K061338 |
05/15/2006 |
DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY |
DADE BEHRING, INC. |
| K962523 |
05/30/1996 |
N LATEX CRP MONO REAGENT |
BEHRING DIAGNOSTICS, INC. |
| K071603 |
06/12/2007 |
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) |
DADE BEHRING, INC. |
| K962373 |
06/20/1996 |
N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2 |
BEHRING DIAGNOSTICS, INC. |
| K962406 |
06/21/1996 |
N CRP STANDARD SY |
BEHRING DIAGNOSTICS, INC. |
| K962407 |
06/21/1996 |
N/T PROTEIN CONTROL PY |
BEHRING DIAGNOSTICS, INC. |
| K962410 |
06/21/1996 |
N PROTEIN STANDARD PY |
BEHRING DIAGNOSTICS, INC. |
| K061802 |
06/27/2006 |
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH |
DADE BEHRING, INC. |
| K061825 |
06/28/2006 |
DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH |
DADE BEHRING, INC. |
| K061845 |
06/29/2006 |
DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H |
DADE BEHRING, INC. |
| K061852 |
06/30/2006 |
DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH |
DADE BEHRING, INC. |
| K061990 |
07/13/2006 |
DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL |
DADE BEHRING, INC. |
| K062035 |
07/19/2006 |
DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL |
DADE BEHRING, INC. |
| K062055 |
07/20/2006 |
DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH |
DADE BEHRING, INC. |
| K162298 |
08/16/2016 |
LOCI Total Vitamin D Total Assay, LOCI VITD CAL |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K072965 |
10/22/2007 |
DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON |
DADE BEHRING, INC. |
| K063272 |
10/30/2006 |
DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH |
DADE BEHRING, INC. |
| K063322 |
11/03/2006 |
DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H |
DADE BEHRING, INC. |
| K063425 |
11/13/2006 |
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH |
DADE BEHRING, INC. |
| K955278 |
11/17/1995 |
BEHRING COAGULATION TIMER |
BEHRING DIAGNOSTICS, INC. |
| K964595 |
11/18/1996 |
OPUS PSA TEST SYSTEM |
BEHRING DIAGNOSTICS, INC. |
| K063610 |
12/04/2006 |
DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH |
DADE BEHRING, INC. |
| K063608 |
12/04/2006 |
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH |
DADE BEHRING, INC. |
| K955596 |
12/08/1995 |
N LATEX B2-MICROGLOBULIN REAGENT |
BEHRING DIAGNOSTICS, INC. |
| K063663 |
12/08/2006 |
DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H |
DADE BEHRING, INC. |
| K063655 |
12/08/2006 |
DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH |
DADE BEHRING, INC. |
| K955858 |
12/27/1995 |
N/T PROTEIN CONTROL SY/L, M AND H |
BEHRING DIAGNOSTICS, INC. |
| K955857 |
12/27/1995 |
N PROTEIN STANDARS SY |
BEHRING DIAGNOSTICS, INC. |
| K143720 |
12/29/2014 |
Dimension Vista MMB Assay |
Siemens Healthcare Diagnostics |
| K041438 |
06/01/2004 |
ADVANCED D-DIMER ASSAY |
DADE BEHRING, INC. |
| K020441 |
02/11/2002 |
EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY |
DADE BEHRING, INC. |
| K090594 |
03/05/2009 |
DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K031512 |
05/14/2003 |
EMIT II PLUS COCAINE METABOLITE ASSAY |
DADE BEHRING, INC. |
| K051597 |
06/16/2005 |
STRATUS CS D-DIMER |
DADE BEHRING, INC. |
| K081732 |
06/19/2008 |
INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K032014 |
06/30/2003 |
N LATEX IGM |
DADE BEHRING, INC. |
| K041878 |
07/12/2004 |
N LATEX CYSTATIN |
DADE BEHRING, INC. |
| K032237 |
07/21/2003 |
N/T PROTEIN CONTROL |
DADE BEHRING, INC. |
| K042735 |
10/01/2004 |
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) |
DADE BEHRING, INC. |
| K052788 |
10/03/2005 |
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H |
DADE BEHRING, INC. |
| K053075 |
11/01/2005 |
N ANTISERA TO HUMAN TRANSFERRIN |
DADE BEHRING, INC. |
| K053074 |
11/01/2005 |
N ANTISERA TO HUMAN CERULOPLASMIN |
DADE BEHRING, INC. |
| K053073 |
11/01/2005 |
N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN |
DADE BEHRING, INC. |
| K053072 |
11/01/2005 |
N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN |
DADE BEHRING, INC. |
| K063351 |
11/06/2006 |
DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH |
DADE BEHRING, INC. |
| K093626 |
11/24/2009 |
INNOVANCE D-DIMER, MODEL OPBP09 |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K024038 |
12/06/2002 |
N LATEX IGA |
DADE BEHRING, INC. |
| K033908 |
12/17/2003 |
N HIGH SENSITIVITY CRP |
DADE BEHRING, INC. |
| K110169 |
01/20/2011 |
DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K110303 |
02/01/2011 |
STRATUS CS ACUTE CARE D-DIMER |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K091916 |
06/30/2009 |
INNOVANCE D-DIMER, MODEL OPBP09 |
SIEMENS HEALTHCARE DIAGNOSTICS |
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