510(k) K133002

i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials by Abbott Point of Care, Inc. — Product Code DHA

K133002 is an FDA 510(k) premarket notification submitted by Abbott Point of Care, Inc. for the device "i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials". The FDA issued a decision of Substantially Equivalent on April 16, 2015. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Abbott Point of Care, Inc. has at least 10 other 510(k) clearances on record.