510(k) K993837

AVL OPTI CRITICAL CARE ANALYZER by Avl Scientific Corp. — Product Code CGA

K993837 is an FDA 510(k) premarket notification submitted by Avl Scientific Corp. for the device "AVL OPTI CRITICAL CARE ANALYZER". The FDA issued a decision of Substantially Equivalent on December 16, 1999. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Avl Scientific Corp. has at least 10 other 510(k) clearances on record.