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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: CDN Applicant: Ortho-Clinical Diagnostics, Inc. Decision Date To: 06/03/2023
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vitros xt chemistry products urea-crea slides Ortho-Clinical Diagnostics, Inc. K190326 03/14/2019
vitros chemistry products bun/urea slides and vitros chemistry products calibrator kit 1 Ortho-Clinical Diagnostics, Inc. K001885 07/20/2000
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