510(k) K913236

STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY by Baxter Healthcare Corp — Product Code DHA

K913236 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on Aug 16, 1991. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Baxter Healthcare Corp has 507 other 510(k) clearances on record.