| Document Date: 2013-01-09 11:27:12
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Company Tosoh Bioscience Inc / SEBIA Inc. / Tosoh Piano EVO3 software Software / Canterbury Scientific / Vinci / / Country United States / / Event FDA Phase / / Facility New Harmpshire Avenue Document Control Center / / / IndustryTerm manufacturing facility / stock solution / announcements concerning your device / predicate device / manufacturing practice requirements / manufacturing / marketed predicate devices / manufacturing practice / / Organization G8 / Food and Drug Administration / Federal Communications Commission / FDA / New Harmpshire Avenue Document Control Center / / Person Karen Anderson / / / Position CAPILARYS Hb / CAPILL4RYS Hb / Hb Alc CAPILLARY Calibrators Hb / Hb Aic CAPILLARYS Calibrator / Hb / MANUFACTURE AND MANUFACTURING CONTROLS The CAPILLARYS Hb / hemoglobin Ale Calibrator / minor Hb / CAPILLARYS Hb / Hemoglobin Aic Calibrator / CAPILLARYS Hb Aic Calibrator / ITEMS Hb Alic CAPILLARYS Calibrator / Hemoglobin Aic Calibrator Set SEBIA HbAlc CAPILLARY CALIBRATORS The Hemoglobin Aic Calibrator / FLEX PIERCING instrument STANDARDS CAPILLARYS Hb / REGULATORY STATUS The CAPILLARYS Hb / calibrator / uzo CAPILLARYS Hb / NGSP IFCC CAPILLARYS Hb / HbAlc CAPILLARY CONTROLS Glycohemoglobin The Hb / EDTA anticoagulant CAPILLARYS Hb / THE PROCEDURES The CAPILLARYS Hb / filters CAPILLARYS Hb / Variant Elution Buffer Hsi HbAlc Calibrator / CAPI LLARYS Hb / CAPILLARYS Calibrator / Barcode label HbAilc CAPILLARYS Calibrator / / Product Federal Food / K112550 / / Technology Bar code / electrophoresis / electrophoresis system / Ale / /
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K uzo CAPILLARYS Hb Aic using the CAPILLARYS 2 FLEX PIERCING instrument I. DEC