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Bayer Healthcare, LLC

7 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality c recall (Z-2482-2015)Bayer Healthcare, LLC2015-08-29
Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobi recall (Z-0136-2014)Bayer Healthcare Llc2013-11-02
Contour, Contour TS Blood Glucose Test Strips and Bonus Packs Intended for self-testing by recall (Z-3268-2011)Bayer Healthcare, LLC2011-09-19
Bayer Contour TS blood glucose monitoring system with 10 blood glucose test strips enclose recall (Z-0931-2008)Bayer Healthcare LLC2008-03-13
Bayer Contour TS blood glucose test strips packaged in packs of 10, 25, 50 and 100 strips; recall (Z-0932-2008)Bayer Healthcare LLC2008-03-13
Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 71 recall (Z-1001-2007)Bayer Healthcare LLC2007-07-03
Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and recall (Z-1051-04)Bayer Healthcare LLC2004-07-20

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Every clearance here is in the API, with alerts when new ones post.