|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
vitros immunodiagnostic products testosterone assay
|
Ortho-Clinical Diagnostics, Inc.
|
K983507 |
11/04/1998
|
vitro chemistry products eco2 slide & calibrator kit 2
|
Ortho-Clinical Diagnostics, Inc.
|
K001133 |
04/24/2000
|
vitros chemistry products crea slide, virtros chemistry products calibrator kit 1
|
Ortho-Clinical Diagnostics, Inc.
|
K001310 |
05/05/2000
|
vitros chemistry products alb slide, vitros chemistry products calibrator kit 4
|
Ortho-Clinical Diagnostics, Inc.
|
K023875 |
12/10/2002
|
vitros chemistry products mg slide, vitros chemistry products calibrator kit 1
|
Ortho-Clinical Diagnostics, Inc.
|
K023876 |
12/10/2002
|
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 aat reagent, calibrator kit 99 and aat performance verifiers i, ii and iii
|
Ortho-Clinical Diagnostics, Inc.
|
K052819 |
12/23/2005
|
vitros chemistry products calibrator kit 99, vitros chemistry products aat/hpt performance verifier i, ii, and iii
|
Ortho-Clinical Diagnostics, Inc.
|
K060940 |
04/24/2006
|
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 crsc slides, vitros chemistry products dt calibrator kit, model 680 2721, 195 7927
|
Ortho-Clinical Diagnostics, Inc.
|
K071216 |
05/25/2007
|