510(k) K955707

ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT by Excel Scientific, Inc. — Product Code DHA

K955707 is an FDA 510(k) premarket notification submitted by Excel Scientific, Inc. for the device "ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT". The FDA issued a decision of Substantially Equivalent on May 2, 1996. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Excel Scientific, Inc. has at least 7 other 510(k) clearances on record.