510(k) K955355

VARIANT ALPHA-THALASSEMIA SHORT PROGRAM by Bio-Rad — Product Code GKA

K955355 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "VARIANT ALPHA-THALASSEMIA SHORT PROGRAM". The FDA issued a decision of Substantially Equivalent on April 26, 1996. The device falls under product code GKA (Abnormal Hemoglobin Quantitation), a Class II device regulated under 21 CFR 864.7415. Bio-Rad has at least 10 other 510(k) clearances on record.