|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
vitros xt chemistry products urea-crea slides
|
Ortho-Clinical Diagnostics, Inc.
|
K190326 |
03/14/2019
|
vitros chemistry products crbm slides, vitros chemistry products crea slides, vitros chemistry products tbil slides, vitros xt 7600 integrated system
|
Ortho-Clinical Diagnostics, Inc.
|
K182063 |
10/30/2018
|
vitros chemistry products crsc slides, vitros chemistry products dt calibrator kit, model 680 2721, 195 7927
|
Ortho-Clinical Diagnostics, Inc.
|
K071216 |
05/25/2007
|
vitros chemistry products urcr slides, vitros chemistry products dt calibrator kit, model 680 2722, 195 7927
|
Ortho-Clinical Diagnostics, Inc.
|
K071215 |
05/25/2007
|
vitros chemistry products crea slides,model# 6802584, vitros chemistry products calibrator kit 1,model#1882208
|
Ortho-Clinical Diagnostics, Inc.
|
K063591 |
12/15/2006
|
vitros chemistry products crea slide, virtros chemistry products calibrator kit 1
|
Ortho-Clinical Diagnostics, Inc.
|
K001310 |
05/05/2000
|