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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 5 of 5 Results
ProductCode: CGX Applicant: HORIBA ABX Decision Date To: 05/10/2024
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yumizen c1200 calcium as, yumizen c1200 creatinine jaffe Horiba ABX SAS K191396 07/26/2019
abx pentra creatinine 120 cp; abx pentra multical; abx pentra n control; abx pentra p control; abx pentra urine control HORIBA ABX S.A.S. K110530 04/30/2012
abx pentra creatinine 120 cp, total protein 100 cp, multical, n and p controls, and urine control l/h HORIBA ABX K072115 11/30/2007
abx pentra 400, calcium cp, creatinine cp, phosphorus cp, amylase cp, urine control l/h HORIBA ABX K070249 04/26/2007
general chemistries on abx pentra 400 clinical chemistry analyzer HORIBA ABX K060205 07/21/2006
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