FDA 510(k) Applications Submitted by LAURA J. DUGGAN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K132638 |
08/23/2013 |
DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE |
Siemens Healthcare Diagnostics Inc. |
| K133728 |
12/06/2013 |
DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE |
Siemens Healthcare Diagnostics Inc. |
| K160202 |
01/28/2016 |
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K190675 |
03/15/2019 |
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay |
Siemens Healthcare Diagnostics, Inc. |
| K161494 |
06/01/2016 |
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) |
Siemens Healthcare Diagnostics, Inc. |
| K151767 |
06/30/2015 |
Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K182225 |
08/16/2018 |
Dimension Vista High-Sensitivity Troponin I (TNIH) Assay |
Siemens Healthcare Diagnostics, Inc. |
| K162399 |
08/26/2016 |
Atellica CH Magnesium (Mg) |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K163220 |
11/16/2016 |
Atellica CH Phencyclidine (Pcp) |
Siemens Healthcare Diagnostics, Inc. |
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