510(k) K960120

STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS by Nova Biomedical Corp. — Product Code JFP

K960120 is an FDA 510(k) premarket notification submitted by Nova Biomedical Corp. for the device "STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS". The FDA issued a decision of Substantially Equivalent on March 11, 1996. The device falls under product code JFP (Electrode, Ion Specific, Calcium), a Class II device regulated under 21 CFR 862.1145. Nova Biomedical Corp. has at least 10 other 510(k) clearances on record.