510(k) K862838

CYTOTECH HSV IGG ENZYME IMMUNOASSAY by Cytotech, Inc. — Product Code GCO

K862838 is an FDA 510(k) premarket notification submitted by Cytotech, Inc. for the device "CYTOTECH HSV IGG ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on December 9, 1986. The device falls under product code GCO (Endoscope, Mirror), a Class II device regulated under 21 CFR 876.1500. Cytotech, Inc. has at least 9 other 510(k) clearances on record.