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U.S. Department of Health and Human Services

510(k) Premarket Notification
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11 to 20 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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Export all 500 Records to ExcelExport to Excel | Download Files | More About 510(k)
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510(K)
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healgen accurate urine drug screen dip card; healgen accurate home urine drug test dip card Healgen Scientific LLC K240686 04/12/2024
maglumi 25-oh vitamin d, maglumi x3 fully-auto chemiluminescence immunoassay analyzer Shenzhen New Industries Biomedical Engineering Co., Ltd K232587 04/12/2024
azer scientific universal transport medium Azer Scientific, Inc. K202531 04/11/2024
safecare fentanyl urine test cassette; safecare fyl urine test cassette Safecare Biotech (Hangzhou) Co., Ltd. K240654 04/10/2024
sample preservation solution Zhejiang GENE SCIENCE Co., Ltd. K212878 04/08/2024
aceso early pregnancy test Aceso Laboratories, Inc. K234152 04/05/2024
advia centaur® tsh3-ultra ii (tsh3ulii) Siemens Healthcare Diagnostics, Inc. K233050 04/04/2024
capi 3 neonat hb, capillarys 3 dbs instrument Sebia K232027 04/04/2024
lifescale gram negative kit (lsgn) with the lifescale ast system Affinity Biosensors K211815 04/02/2024
citrated: k, kh, rth, ffh Haemonetics Corporation K232018 03/29/2024

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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