510(k) K051072

BIO-RAD VARIANT NBS SICKLE CELL PROGRAM by Bio-Rad Laboratories, Inc. — Product Code GKA

K051072 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories, Inc. for the device "BIO-RAD VARIANT NBS SICKLE CELL PROGRAM". The FDA issued a decision of Substantially Equivalent on May 12, 2005. The device falls under product code GKA (Abnormal Hemoglobin Quantitation), a Class II device regulated under 21 CFR 864.7415. Bio-Rad Laboratories, Inc. has at least 10 other 510(k) clearances on record.