FDA 510(k) Applications Submitted by HELEN LEE
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K071247 |
05/04/2007 |
N LATEX RF KIT |
DADE BEHRING, INC. |
| K140790 |
03/31/2014 |
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K081161 |
04/24/2008 |
DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST |
DADE BEHRING, INC. |
| K081789 |
06/25/2008 |
DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR |
Siemens Healthcare Diagnostics Inc. |
| K102772 |
09/24/2010 |
DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL) |
SIEMENS HEATLHCARE DIAGNOSTICS INC |
| K072717 |
09/25/2007 |
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 |
DADE BEHRING, INC. |
| K063508 |
11/20/2006 |
DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN |
DADE BEHRING, INC. |
| K083445 |
11/21/2008 |
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K083462 |
11/24/2008 |
DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350 |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K073561 |
12/19/2007 |
DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR |
DADE BEHRING, INC. |
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