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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 6 of 6 Results
ProductCode: JFY Applicant: Ortho-Clinical Diagnostics, Inc. Decision Date To: 12/02/2022
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vitros xt chemistry products urea-crea slides Ortho-Clinical Diagnostics, Inc. K190326 03/14/2019
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 chemistry products crsc slides, vitros chemistry products dt calibrator kit, model 680 2721, 195 7927 Ortho-Clinical Diagnostics, Inc. K071216 05/25/2007
vitros chemistry products urcr slides, vitros chemistry products dt calibrator kit, model 680 2722, 195 7927 Ortho-Clinical Diagnostics, Inc. K071215 05/25/2007
vitros chemistry products crea slides,model# 6802584, vitros chemistry products calibrator kit 1,model#1882208 Ortho-Clinical Diagnostics, Inc. K063591 12/15/2006
vitros chemistry products crea slide, virtros chemistry products calibrator kit 1 Ortho-Clinical Diagnostics, Inc. K001310 05/05/2000
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