510(k) K090413

A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC by Bayer Healthcare, LLC — Product Code LCP

K090413 is an FDA 510(k) premarket notification submitted by Bayer Healthcare, LLC for the device "A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC". The FDA issued a decision of Substantially Equivalent on May 14, 2009. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Bayer Healthcare, LLC has at least 10 other 510(k) clearances on record.