|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
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 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 hscrp reagent, vitros chemistry products calibrator kit 17, vitros chemistry products fs
|
Ortho-Clinical Diagnostics, Inc.
|
K041799 |
08/25/2004
|
vitros immunodiagnostic products troponin i reagent pack and calibrators
|
Ortho-Clinical Diagnostics, Inc.
|
K031031 |
09/29/2003
|
vitros chemistry products crp slide and calibrator kit 7
|
Ortho-Clinical Diagnostics, Inc.
|
K030626 |
03/18/2003
|