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U.S. Department of Health and Human Services

510(k) Premarket Notification
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141 to 150 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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etest® sulbactam/durlobactam (sud) (0.004/4-64/4 µg/ml), etest® sud bioMérieux K232395 10/05/2023
evidence multistat doa urine multiplex Randox Laboratories Limited K221550 10/05/2023
evidence multistat doa urine multiplex, evidence multistat Randox Laboratories Limited K220451 10/05/2023
tandem mobi insulin pump with interoperable technology Tandem Diabetes Care Inc. K233044 10/05/2023
endo.digital platform DreaMed Diabetes Ltd K232722 10/03/2023
elecsys tg ii Roche Diagnostics K221890 09/30/2023
acl top 970 cl, hemosil cl anti-cardiolipin igm, hemosil cl anti-ß2 glycoprotein-i igm Instrumentation Laboratory Co. K221359 09/29/2023
anemocheck home Sanguina, Inc. K221508 09/29/2023
aptiva ctd essential reagent Inova Diagnostics, Inc. K213403 09/29/2023
dynex smartplex mmrv igg assay kit Dynex Technologies Inc. K212769 09/29/2023

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