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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: JJE Applicant: SIEMENS HEALTHCARE DIAGNOSTICS, INC. Decision Date To: 05/29/2024
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emit® ii plus buprenorphine assay Siemens Healthcare Diagnostics, Inc. K221605 07/25/2023
trinidad ch system, td-lyte integrated multisensor (na, k, ci), td-lyte imt standard a, td-lyte imt standard b + salt bridge, trinidad ch albumin bcp reagent (alb_p), trinidad ch albumin bcp calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC. K151767 12/11/2015
dimension exl with lm system SIEMENS HEALTHCARE DIAGNOSTICS, INC. K130276 03/22/2013
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