|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
vitros 5,1 fs chemistry system with engen laboratory automation system
|
Ortho-Clinical Diagnostics, Inc.
|
K063144 |
11/13/2006
|
vitros chemistry product malb reagent, calibrator kit 24, malb performance verifiers i and ii
|
Ortho-Clinical Diagnostics, Inc.
|
K042643 |
11/18/2004
|
vitros chemistry products apoa1 and apob reagents, calibrator kits 21 and 22 and apoa1 and apob performance verifiers
|
Ortho-Clinical Diagnostics, Inc.
|
K042521 |
11/18/2004
|
vitros chemistry products calibrator kit 23; vitros chemistry products palb performance verifiers i & ii
|
Ortho-Clinical Diagnostics, Inc.
|
K042838 |
12/09/2004
|
vitros chemistry products crp slide and calibrator kit 7
|
Ortho-Clinical Diagnostics, Inc.
|
K030626 |
03/18/2003
|
vitros chemistry products d%a1c reagent kit, model 680 2314; vitros chemistry products calibrator kit 18, model 680 1702
|
Ortho-Clinical Diagnostics, Inc.
|
K060650 |
04/06/2006
|
vitros chemistry products dldl reagent, calibrator kit 19, fs calibrator 1 and performance verifiers i and ii
|
Ortho-Clinical Diagnostics, Inc.
|
K041720 |
08/25/2004
|
vitros chemistry products hcy reagent, vitros chemistry products calibrator kit 27, hcy performance verifiers
|
Ortho-Clinical Diagnostics, Inc.
|
K061588 |
07/21/2006
|
vitros chemistry products hscrp reagent, vitros chemistry products calibrator kit 17, vitros chemistry products fs
|
Ortho-Clinical Diagnostics, Inc.
|
K041799 |
08/25/2004
|
vitros chemistry products tibc kit, model 886 7541; calibrator kit 4, model 120 4668
|
Ortho-Clinical Diagnostics, Inc.
|
K061464 |
06/15/2006
|