510(k) K080911

VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH by Bio-Rad Laboratories Inc., Clinical Systems Divisi — Product Code GKA

K080911 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories Inc., Clinical Systems Divisi for the device "VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH". The FDA issued a decision of Substantially Equivalent on May 2, 2008. The device falls under product code GKA (Abnormal Hemoglobin Quantitation), a Class II device regulated under 21 CFR 864.7415. Bio-Rad Laboratories Inc., Clinical Systems Divisi has at least 2 other 510(k) clearances on record.