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U.S. Department of Health and Human Services

510(k) Premarket Notification

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ProductCode: JLW Applicant: ORTHO-CLINICAL DIAGNOSTICS Decision Date To: 12/08/2022
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vitros immunodiagnostic products tsh reagent pack and calibrators, vitros 3600 immunodiagnostic system ORTHO-CLINICAL DIAGNOSTICS K083173 12/22/2008
vitros immunodiagnostic products tsh reagent pack and calibrators, vitros 5600 integrated system Ortho-Clinical Diagnostics, Inc. K081543 10/23/2008
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