510(k) K801422

SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS. by Sandare Chemical Co., Inc. — Product Code LCP

K801422 is an FDA 510(k) premarket notification submitted by Sandare Chemical Co., Inc. for the device "SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS.". The FDA issued a decision of Substantially Equivalent on July 8, 1980. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Sandare Chemical Co., Inc. has at least 10 other 510(k) clearances on record.