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U.S. Department of Health and Human Services

510(k) Premarket Notification

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81 to 90 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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510(K)
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abx micros es 60 ct; (open tube model), (close tube model) HORIBA ABX SAS K141161 12/20/2014
abx micros es 60 ot and abx micros es 60 ct HORIBA ABX SAS K170353 11/01/2017
abx pentra 400 : crp HORIBA ABX K061138 09/29/2006
abx pentra 400 clinical chemistry analyzer (option: i.s.e. module) HORIBA ABX K052007 12/16/2005
abx pentra 400, calcium cp, creatinine cp, phosphorus cp, amylase cp, urine control l/h HORIBA ABX K070249 04/26/2007
abx pentra 400: lipoproteins HORIBA ABX K060854 08/24/2006
abx pentra albumin cp, abx pentra micro-albumin cp, abx pentra total protein cp, abx pentra multical HORIBA ABX K060434 06/05/2007
abx pentra amylase cp; multical; n control; p control; clean-chem cp; clean-chem 99 cp HORIBA ABX K062180 10/02/2006
abx pentra bilirubin, direct cp, abx pentra bilirubin, total cp, abx pentra multical, abx pentra n control, abx pentra p HORIBA ABX K060325 08/16/2006
abx pentra calcium as cp, abx pentra urine control l/h, abx pentra multical, abx pentra n control, and abx pentra p cont HORIBA ABX S.A.S. K123171 07/03/2013

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