510(k) K011953

WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA by Wiener Laboratories Saic — Product Code CGA

K011953 is an FDA 510(k) premarket notification submitted by Wiener Laboratories Saic for the device "WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA". The FDA issued a decision of Substantially Equivalent on December 21, 2001. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Wiener Laboratories Saic has at least 10 other 510(k) clearances on record.