510(k) K974512

AIMSTICK PBD COMBO PREGNANCY by Germaine Laboratories, Inc. — Product Code DHA

K974512 is an FDA 510(k) premarket notification submitted by Germaine Laboratories, Inc. for the device "AIMSTICK PBD COMBO PREGNANCY". The FDA issued a decision of Substantially Equivalent on January 2, 1998. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Germaine Laboratories, Inc. has at least 7 other 510(k) clearances on record.