FDA 510(k) Applications Submitted by GEORGE W PLUMMER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K010313 |
02/02/2001 |
DIMENSION CTNI FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K010314 |
02/02/2001 |
DIMENSION CTNI CALIBRATOR |
DADE BEHRING, INC. |
| K060628 |
03/09/2006 |
DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR |
DADE BEHRING, INC. |
| K020980 |
03/26/2002 |
DIMENSION TPSA CALIBRATOR, MODEL #RC459 |
DADE BEHRING, INC. |
| K031343 |
04/29/2003 |
TPSA FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K081319 |
05/12/2008 |
DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56 |
Siemens Healthcare Diagnostics Inc. |
| K071474 |
05/29/2007 |
DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K061839 |
06/29/2006 |
DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125 |
DADE BEHRING, INC. |
| K081857 |
07/01/2008 |
DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 |
Siemens Healthcare Diagnostics Inc. |
| K071834 |
07/03/2007 |
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM |
DADE BEHRING, INC. |
| K042347 |
08/30/2004 |
MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD |
DADE BEHRING, INC. |
| K033487 |
11/04/2003 |
STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI |
DADE BEHRING, INC. |
| K043476 |
12/16/2004 |
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT |
DADE BEHRING, INC. |
| K063756 |
12/19/2006 |
DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K003963 |
12/22/2000 |
DIMENSION PSA FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
| K053576 |
12/22/2005 |
DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR |
DADE BEHRING, INC. |
| K053577 |
12/22/2005 |
DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT |
DADE BEHRING, INC. |
| K061719 |
06/19/2006 |
DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212 |
DADE BEHRING, INC. |
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