510(k) K092849

BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER by Epocal, Inc. — Product Code CEM

K092849 is an FDA 510(k) premarket notification submitted by Epocal, Inc. for the device "BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER". The FDA issued a decision of Substantially Equivalent on March 30, 2010. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Epocal, Inc. has at least 6 other 510(k) clearances on record.