FDA 510(k) Applications Submitted by FRANCES A DILLON
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140842 |
04/02/2014 |
DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART |
Siemens Healthcare Diagnostics Inc. |
| K140859 |
04/03/2014 |
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT |
Siemens Healthcare Diagnostics Inc. |
| K121084 |
04/10/2012 |
LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L |
Siemens Healthcare Diagnostics Inc. |
| K093441 |
11/05/2009 |
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 |
SIEMENS HEALTHCARE DIAGNOSTICS |
| K113373 |
11/16/2011 |
DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL |
Siemens Healthcare Diagnostics Inc. |
| K150606 |
03/10/2015 |
Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
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