510(k) K062434

ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 by Agamatrix — Product Code NBW

K062434 is an FDA 510(k) premarket notification submitted by Agamatrix for the device "ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528". The FDA issued a decision of Substantially Equivalent on November 13, 2006. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Agamatrix has at least 10 other 510(k) clearances on record.