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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 19 Results
ProductCode: JIX Applicant: Ortho-Clinical Diagnostics, Inc. Decision Date To: 09/25/2022
 
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vitros chemistry products calibrator kit 3 ORTHO-CLINICAL DIAGNOSTICS, INC. K161140 05/20/2016
vitros chemistry products na + dt slides, model 153 2290 and dt calibrator kit, model 195 7927 Ortho-Clinical Diagnostics, Inc. K091861 09/03/2009
vitros chemistry products k+dt slides: vitros chemistry products dt calibrator kit, model k+dt slides: 153 2258 Ortho-Clinical Diagnostics, Inc. K083680 02/27/2009
vitros chemistry products ci-dt slides; vitros chemistry products dt calibrator kit, models ci-dt slides:131 4905 Ortho-Clinical Diagnostics, Inc. K082099 08/21/2008
vitros chemistry products k+ slides and calibrator kit 2 Ortho-Clinical Diagnostics, Inc. K073157 12/07/2007
vitros chemistry products ca dt slides and dt calibrator kit and vitros ca assay Ortho-Clinical Diagnostics, Inc. K072443 09/24/2007
vitros chemistry products: ca slides (model: 145 0261), calibrators kit 1 (model: 188 2208) Ortho-Clinical Diagnostics, Inc. K072440 09/20/2007
vitros chemistry products ci-slides, calibrator kit 2, model(s) 844-5207, 166-2659 Ortho-Clinical Diagnostics, Inc. K071801 07/20/2007
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
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