510(k) K875101

VIROGEN CMV ANTIBODY TEST by Wampole Laboratories — Product Code LQO

K875101 is an FDA 510(k) premarket notification submitted by Wampole Laboratories for the device "VIROGEN CMV ANTIBODY TEST". The FDA issued a decision of Substantially Equivalent on March 1, 1988. The device falls under product code LQO (Dna-Reagents, Campylobacter Spp.), a Class I device regulated under 21 CFR 866.3110. Wampole Laboratories has at least 10 other 510(k) clearances on record.