|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
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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® automation solutions
|
Ortho-Clinical Diagnostics, Inc.
|
K160495 |
10/18/2016
|
vitros immunodiagnostic products tsh reagent pack and calibrators, vitros 3600 immunodiagnostic system
|
ORTHO-CLINICAL DIAGNOSTICS
|
K083173 |
12/22/2008
|
vitros immunodiagnostic products tsh reagent pack and calibrators, vitros 5600 integrated system
|
Ortho-Clinical Diagnostics, Inc.
|
K081543 |
10/23/2008
|
vitros 5,1 fs chemistry system with engen laboratory automation system
|
Ortho-Clinical Diagnostics, Inc.
|
K063144 |
11/13/2006
|
vitros 5,1 fs chemistry system, vitros chemistry products dhdl reagent pack, calibrator kit 19, fs calibrator 1
|
ORTHO-CLINICAL DIAGNOSTICS
|
K031924 |
08/07/2003
|