510(k) K161364

BinaxNOW G6PD Test by Alere Scarborough, Inc. — Product Code JBF

K161364 is an FDA 510(k) premarket notification submitted by Alere Scarborough, Inc. for the device "BinaxNOW G6PD Test". The FDA issued a decision of Substantially Equivalent on June 17, 2016. The device falls under product code JBF (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening), a Class II device regulated under 21 CFR 864.7360. Alere Scarborough, Inc. has at least 10 other 510(k) clearances on record.