510(k) K991127

VARIANT II B-THALASSEMIA by Bio-Rad — Product Code JPD

K991127 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "VARIANT II B-THALASSEMIA". The FDA issued a decision of Substantially Equivalent on June 10, 1999. The device falls under product code JPD (Hemoglobin A2 Quantitation), a Class II device regulated under 21 CFR 864.7400. Bio-Rad has at least 10 other 510(k) clearances on record.