FDA 510(k) Applications Submitted by ANNA MARIE ENNIS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K083463 |
11/24/2008 |
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K093645 |
11/25/2009 |
EXL ANEM CAL, MODEL RC640 |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K130698 |
03/14/2013 |
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL) |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K101460 |
05/26/2010 |
LOCI 8 CALIBRATOR, MODEL KC 646 |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K071980 |
07/18/2007 |
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H |
DADE BEHRING, INC. |
| K102510 |
08/27/2010 |
DIMENSIONS HB1C KIT, MODEL DF105A |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K150168 |
01/26/2015 |
Dimension Tacrolimus Flex« Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K081249 |
05/02/2008 |
DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM |
DADE BEHRING, INC. |
| K082503 |
08/29/2008 |
DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K093631 |
11/24/2009 |
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K133512 |
11/15/2013 |
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K103612 |
12/09/2010 |
DIMENSION VISA ENZ 2 CAL |
SIEMENS HEALTHCARE DIAGNOSTICS INC |
| K103836 |
12/30/2010 |
ENZYME II CALIBRATOR |
SIEMENS HEALTHCARE DIAGNOSTICS INC |
| K102045 |
07/21/2010 |
DIMENSION VISA HBA1C, MODEL K3105A |
SIEMENS HEATLHCARE DIAGNOSTICS INC |
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