FDA 510(k) Applications Submitted by PAMELA A JURGA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K100375 |
02/12/2010 |
DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 |
Siemens Healthcare Diagnostics Inc. |
| K130276 |
02/05/2013 |
DIMENSION EXL WITH LM SYSTEM |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K060548 |
03/01/2006 |
STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK |
DADE BEHRING, INC. |
| K081300 |
05/08/2008 |
DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K071597 |
06/12/2007 |
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 |
DADE BEHRING, INC. |
| K051650 |
06/21/2005 |
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. |
DADE BEHRING, INC. |
| K071767 |
06/29/2007 |
DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A |
DADE BEHRING, INC. |
| K062924 |
09/28/2006 |
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK |
DADE BEHRING, INC. |
| K073072 |
10/31/2007 |
DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B |
DADE BEHRING, INC. |
| K063356 |
11/07/2006 |
STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK |
DADE BEHRING, INC. |
| K063754 |
12/19/2006 |
DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 |
DADE BEHRING, INC. |
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