FDA 510(k) Applications Submitted by YUK-TING LEWIS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K000387 |
02/07/2000 |
TERUMO NEEDLE WITH LOCKING SHEATH |
TERUMO MEDICAL CORP. |
| K060385 |
02/14/2006 |
EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT |
DADE BEHRING, INC. |
| K060502 |
02/24/2006 |
DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 |
DADE BEHRING, INC. |
| K060503 |
02/24/2006 |
DIMENSION TACR CALIBRATOR, MODEL DC107 |
DADE BEHRING, INC. |
| K981359 |
04/14/1998 |
GT LEGGIERO |
TERUMO MEDICAL CORP. |
| K081074 |
04/16/2008 |
DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 |
Siemens Healthcare Diagnostics Inc. |
| K081103 |
04/18/2008 |
LOCI THYROID CALIBRATOR WITH MODEL RC610 |
Siemens Healthcare Diagnostics Inc. |
| K081643 |
06/12/2008 |
DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K081683 |
06/17/2008 |
LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K992051 |
06/18/1999 |
RADIFOCUS OPTITORQUE |
TERUMO MEDICAL CORP. |
| K081992 |
07/14/2008 |
DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 |
Siemens Healthcare Diagnostics Inc. |
| K082030 |
07/17/2008 |
DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 |
Siemens Healthcare Diagnostics Inc. |
| K012812 |
08/22/2001 |
CAROTID GUIDING SHEATH |
TERUMO MEDICAL CORP. |
| K012854 |
08/24/2001 |
RENAL GUIDING SHEATH |
TERUMO MEDICAL CORP. |
| K042407 |
09/03/2004 |
EMIT CAFFEINE ASSAY |
DADE BEHRING, INC. |
| K082638 |
09/10/2008 |
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL |
Siemens Healthcare Diagnostics Inc. |
| K053061 |
10/31/2005 |
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY |
DADE BEHRING, INC. |
| K003424 |
11/03/2000 |
PINNACLE R/O II OR RADIFOCUS INTRODUCER II |
TERUMO MEDICAL CORP. |
| K003425 |
11/03/2000 |
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS |
TERUMO MEDICAL CORP. |
| K043028 |
11/03/2004 |
EMIT II PLUS ECSTASY ASSAY |
DADE BEHRING, INC. |
| K053108 |
11/04/2005 |
DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 |
DADE BEHRING, INC. |
| K984260 |
11/25/1998 |
PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR) |
TERUMO MEDICAL CORP. |
| K083487 |
11/25/2008 |
EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K053337 |
12/01/2005 |
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109 |
DADE BEHRING, INC. |
| K073604 |
12/21/2007 |
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD |
DADE BEHRING, INC. |
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