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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 15 of 15 Results
ProductCode: JIT Applicant: Ortho-Clinical Diagnostics, Inc. Decision Date To: 05/03/2024
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vitros chemistry products trfrn reahent; vitros chemistry products calibrator kit 20; vitros chemistry products protein Ortho-Clinical Diagnostics, Inc. K042477 11/19/2004
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 nt pro-bnp reagent pack,calibrators,range verifiers,680 2156,680 2157,680 2158 Ortho-Clinical Diagnostics, Inc. K060632 06/06/2006
vitros immunodiagnostic products troponin i reagent pack and calibrators Ortho-Clinical Diagnostics, Inc. K031031 09/29/2003
vitros immunodiagnostic products tsh reagent pack and calibrators, vitros 5600 integrated system Ortho-Clinical Diagnostics, Inc. K081543 10/23/2008
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