510(k) K882896

ONE-STEP HCG by Wampole Laboratories — Product Code DHA

K882896 is an FDA 510(k) premarket notification submitted by Wampole Laboratories for the device "ONE-STEP HCG". The FDA issued a decision of Substantially Equivalent on October 31, 1988. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Wampole Laboratories has at least 10 other 510(k) clearances on record.