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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 4 of 4 Results
ProductCode: JJE Applicant: Ortho-Clinical Diagnostics, Inc. Decision Date To: 02/01/2023
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vitros 5,1 fs chemistry system with engen laboratory automation system Ortho-Clinical Diagnostics, Inc. K063144 11/13/2006
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 immunodiagnostic products tsh reagent pack and calibrators, vitros 5600 integrated system Ortho-Clinical Diagnostics, Inc. K081543 10/23/2008
vitros® automation solutions Ortho-Clinical Diagnostics, Inc. K160495 10/18/2016
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