|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
vitros immunodiagnostic products testosterone assay
|
Ortho-Clinical Diagnostics, Inc.
|
K983507 |
11/04/1998
|
vitros chemistry products: ca slides (model: 145 0261), calibrators kit 1 (model: 188 2208)
|
Ortho-Clinical Diagnostics, Inc.
|
K072440 |
09/20/2007
|
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 na + dt slides, model 153 2290 and dt calibrator kit, model 195 7927
|
Ortho-Clinical Diagnostics, Inc.
|
K091861 |
09/03/2009
|
vitros chemistry products mg slide, vitros chemistry products calibrator kit 1
|
Ortho-Clinical Diagnostics, Inc.
|
K023876 |
12/10/2002
|
vitros chemistry products k+dt slides: vitros chemistry products dt calibrator kit, model k+dt slides: 153 2258
|
Ortho-Clinical Diagnostics, Inc.
|
K083680 |
02/27/2009
|
vitros chemistry products k+ slides and calibrator kit 2
|
Ortho-Clinical Diagnostics, Inc.
|
K073157 |
12/07/2007
|
vitros chemistry products igg, iga and igm reagents; vitros chemistry product calibrator kit 20; vitros chemistry produc
|
Ortho-Clinical Diagnostics, Inc.
|
K042475 |
11/10/2004
|
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 crea slides,model# 6802584, vitros chemistry products calibrator kit 1,model#1882208
|
Ortho-Clinical Diagnostics, Inc.
|
K063591 |
12/15/2006
|