Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
1 to 10 of 15 Results
ProductCode: JIT Applicant: Ortho-Clinical Diagnostics, Inc. Decision Date To: 05/03/2024
 
 1 
 2 
 > 
Results per Page
New Search  
Export all 15 Records to ExcelExport to Excel | Download Files | More About 510(k)
Device Name
Sort by Device Name [A-Z]
Sort by Device Name [Z-A]
Applicant
Sort by Applicant [A-Z]
Sort by Applicant [Z-A]
510(K)
Number
Sort by 510(k) Number [0-9]
Sort by 510(k) Number [9-0]
Decision
Date
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
vitros immunodiagnostic products 25-oh vitamin d total reagent pack, vitamin d total calibrators Ortho-Clinical Diagnostics, Inc. K121608 02/15/2013
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 chemistry products hcy reagent, vitros chemistry products calibrator kit 27, hcy performance verifiers Ortho-Clinical Diagnostics, Inc. K061588 07/21/2006
vitros chemistry products tibc kit, model 886 7541; calibrator kit 4, model 120 4668 Ortho-Clinical Diagnostics, Inc. K061464 06/15/2006
vitros immunodiagnostic products nt pro-bnp reagent pack,calibrators,range verifiers,680 2156,680 2157,680 2158 Ortho-Clinical Diagnostics, Inc. K060632 06/06/2006
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 calibrator kit 23; vitros chemistry products palb performance verifiers i & ii Ortho-Clinical Diagnostics, Inc. K042838 12/09/2004
vitros chemistry products trfrn reahent; vitros chemistry products calibrator kit 20; vitros chemistry products protein Ortho-Clinical Diagnostics, Inc. K042477 11/19/2004
vitros chemistry product malb reagent, calibrator kit 24, malb performance verifiers i and ii Ortho-Clinical Diagnostics, Inc. K042643 11/18/2004
-
-