FDA 510(k) Applications Submitted by ROSE T MARINELLI
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K100321 |
02/04/2010 |
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604 |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K100344 |
02/05/2010 |
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K090330 |
02/10/2009 |
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 |
Siemens Healthcare Diagnostics Inc. |
| K100778 |
03/19/2010 |
DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K121907 |
06/29/2012 |
DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K112142 |
07/26/2011 |
DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K122323 |
08/01/2012 |
DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K162540 |
09/12/2016 |
INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls |
SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH |
| K123320 |
10/26/2012 |
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K123321 |
10/26/2012 |
DIMENSION CHEMISTRY III CALIBRATORY |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K103360 |
11/16/2010 |
DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL |
SIEMENS CORP. |
| K123677 |
11/30/2012 |
DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) |
SIEMENS HEALTHCARE DIAGNOSTICS |
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