510(k) K151487

Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method by Diatron U.S., Inc. — Product Code CFR

K151487 is an FDA 510(k) premarket notification submitted by Diatron U.S., Inc. for the device "Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method". The FDA issued a decision of Substantially Equivalent on January 14, 2016. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. Diatron U.S., Inc. has at least 2 other 510(k) clearances on record.