FDA 510(k) Applications Submitted by JANE E PHILLIPS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140112 |
01/15/2014 |
CA 125 II CALSET II |
Roche Diagnostics |
| K210546 |
02/25/2021 |
Elecsys proBNP II, Elecsys proBNP II STAT |
Roche Diagnostics |
| K140534 |
03/04/2014 |
ELECSYS PRECICONTROL TS |
Roche Diagnostics |
| K201441 |
06/01/2020 |
Elecsys Troponin T Gen 5 |
Roche Diagnostics |
| K112624 |
09/08/2011 |
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 |
Roche Diagnostics |
| K082699 |
09/15/2008 |
ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS |
Roche Diagnostics |
| K162895 |
10/17/2016 |
Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 |
Roche Diagnostics |
| K223637 |
12/05/2022 |
Elecsys proBNP II, Elecsys proBNP II STAT |
Roche Diagnostics |
| K131605 |
06/03/2013 |
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY |
Roche Diagnostics |
| K112104 |
07/22/2011 |
ELECSYS N-MID OSTEOCALCIN CALCHECK 5 |
Roche Diagnostics |
| K092649 |
08/28/2009 |
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 |
ROCHE DIAGNOSTICS CORP. |
| K092888 |
09/21/2009 |
ELECSYS TOXO IGG CALCHECK 5 |
ROCHE DIAGNOSTICS CORP. |
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