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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 4 of 4 Results
ProductCode: JGS Applicant: Siemens Healthcare Diagnostics Decision Date To: 04/02/2023
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rapidpoint 500e blood gas system Siemens Healthcare Diagnostics, Inc. K192240 03/27/2020
atellica solution, atellica a-lyte integrated multisensor na+/k+/ci-, atellica ch albumin bcp reagent (alb_p), atellica im thyroid stimulating hormone tsh, atellica ch vancomycin (vanc) Siemens Healthcare Diagnostics K161954 03/09/2017
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 clinical chemistry system SIEMENS HEALTHCARE DIAGNOSTICS K112999 11/22/2011