510(k) K070068

NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS by Nova Biomedical Corp. — Product Code CGL

K070068 is an FDA 510(k) premarket notification submitted by Nova Biomedical Corp. for the device "NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS". The FDA issued a decision of Substantially Equivalent on May 7, 2007. The device falls under product code CGL (Electrode, Ion Based, Enzymatic, Creatinine), a Class II device regulated under 21 CFR 862.1225. Nova Biomedical Corp. has at least 10 other 510(k) clearances on record.