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Horiba Instruments Inc

7 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitat recall (Z-0738-2016)Horiba Instruments Inc2016-02-02
ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative recall (Z-0739-2016)Horiba Instruments Inc2016-02-02
ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro recall (Z-0740-2016)Horiba Instruments Inc2016-02-02
ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in vitro recall (Z-0741-2016)Horiba Instruments Inc2016-02-02
ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantit recall (Z-0742-2016)Horiba Instruments Inc2016-02-02
ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitativ recall (Z-0743-2016)Horiba Instruments Inc2016-02-02
Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model recall (Z-0856-2015)Horiba Instruments Inc2014-12-23

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