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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 27 Results
ProductCode: JIX Applicant: SIEMENS HEALTHCARE DIAGNOSTICS Decision Date To: 05/03/2024
 
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atellica® ch high sensitivity c-reactive protein 2 (hcrp2) Siemens HealthCare Diagnostics Inc. K233242 01/18/2024
n latex cystatin c; n protein standard uy Siemens Healthcare Diagnostics Products GmbH K171072 05/12/2017
advia chemistry enzyme 1 calibrator, advia chemistry enzyme 2 calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC. K153365 12/18/2015
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 vista chemistry 1 calibrator (chem 1 cal), dimension vista magnesium flex reagent cartridge (mg) SIEMENS HEALTHCARE DIAGNOSTICS K140790 06/15/2015
clinitek novus; automated urine chemistry analyzer, 10 urinalysis cassette, calibration kit SIEMENS HEALTHCARE DIAGNOSTICS K140717 11/17/2014
loci vitamin b12 (vb12) flex reagent cartridge, loci anemia calibrator (anem cal) SIEMENS HEALTHCARE DIAGNOSTICS K133512 01/02/2014
advia chemistry albumin bcp reagent (albp), advia chemistry albumin bcp calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC. K132664 10/16/2013
dimension vista; ammonia flex reagent cartridge (amm), chemistry 3 calibrator (chem 3 cal) SIEMENS HEALTHCARE DIAGNOSTICS K123677 03/07/2013
dimension chemistry iii calibratory SIEMENS HEALTHCARE DIAGNOSTICS K123321 02/15/2013
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