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U.S. Department of Health and Human Services

510(k) Premarket Notification
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101 to 110 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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coulter lh 500 hematology analyzer BECKMAN COULTER, INC. K032000 08/13/2003
coulter lh 750 hematology analyzer BECKMAN COULTER, INC. K032342 09/26/2003
cozart eia amphetamines oral fluid microplate kit COZART BIOSCIENCE LTD. K033743 06/03/2004
creatinine reagent kit for beckman synchron cx & cx delta systems DIAMOND DIAGNOSTICS, INC. K033058 01/30/2004
cryocheck weak lupus positive control PRECISION BIOLOGIC K032804 11/03/2003
ct oia THERMO BIOSTAR, INC. K032330 03/02/2004
d-10 hemoglobin a1c BIO-RAD LABORATORIES, INC. K031043 08/27/2003
dakocytomation beta-2-microglobulin kit, code no. oa 368 DAKO A/S K032692 01/22/2004
diascreen reagent strips for urinalysis, models d122oo (2gk), d12100 (1k), d11100 (1g) HYPOGUARD USA, INC. K033851 03/02/2004
diazyme lithium enzymatic assay kit GENERAL ATOMICS K033360 12/23/2003

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