510(k) K842668

LIQUI-HEME HEMOGLOBIN CALIBRATORS by Biodiagnostic Intl — Product Code KRZ

K842668 is an FDA 510(k) premarket notification submitted by Biodiagnostic Intl for the device "LIQUI-HEME HEMOGLOBIN CALIBRATORS". The FDA issued a decision of Substantially Equivalent on March 5, 1985. The device falls under product code KRZ (Calibrator For Hemoglobin And Hematocrit Measurement), a Class II device regulated under 21 CFR 864.8165. Biodiagnostic Intl has at least 10 other 510(k) clearances on record.