FDA 510(k) Applications Submitted by Darlene J Phillips
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K190326 |
02/13/2019 |
VITROS XT Chemistry Products UREA-CREA Slides |
Ortho-Clinical Diagnostics, Inc. |
| K190520 |
03/04/2019 |
VITROS XT Chemistry Products GLU-Ca Slides |
Ortho-Clinical Diagnostics, Inc. |
| K210858 |
03/23/2021 |
VITROS Chemistry Products PHBR Slides |
Ortho-Clinical Diagnostics, Inc. |
| K190807 |
03/29/2019 |
VITROS XT Chemistry Products TBIL-ALKP Slides |
Ortho-Clinical Diagnostics, Inc. |
| K001266 |
04/20/2000 |
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA |
Ortho-Clinical Diagnostics, Inc. |
| K191316 |
05/15/2019 |
VITROS XT Chemistry Products ALB-TP Slides |
Ortho-Clinical Diagnostics, Inc. |
| K160495 |
02/22/2016 |
VITROS« Automation Solutions |
Ortho-Clinical Diagnostics, Inc. |
| K030626 |
02/27/2003 |
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7 |
Ortho-Clinical Diagnostics, Inc. |
| K011463 |
05/14/2001 |
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS |
ORTHO-CLINICAL DIAGNOSTICS |
| K061464 |
05/25/2006 |
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 |
Ortho-Clinical Diagnostics, Inc. |
| K001769 |
06/12/2000 |
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT |
ORTHO-CLINICAL DIAGNOSTICS |
| K062094 |
07/24/2006 |
VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V |
Ortho-Clinical Diagnostics, Inc. |
| K042006 |
07/26/2004 |
VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE |
Ortho-Clinical Diagnostics, Inc. |
| K062285 |
08/07/2006 |
VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV |
Ortho-Clinical Diagnostics, Inc. |
| K062637 |
09/05/2006 |
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V |
Ortho-Clinical Diagnostics, Inc. |
| K042477 |
09/13/2004 |
VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN |
Ortho-Clinical Diagnostics, Inc. |
| K042494 |
09/14/2004 |
VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III |
ORTHO-CLINICAL DIAGNOSTICS |
| K042643 |
09/27/2004 |
VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II |
Ortho-Clinical Diagnostics, Inc. |
| K052819 |
10/04/2005 |
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III |
Ortho-Clinical Diagnostics, Inc. |
| K052867 |
10/11/2005 |
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT |
Ortho-Clinical Diagnostics, Inc. |
| K042838 |
10/14/2004 |
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II |
Ortho-Clinical Diagnostics, Inc. |
| K163433 |
12/07/2016 |
VITROS Chemistry Products GLU Slides |
Ortho Clinical Diagnostics |
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