510(k) K924857

AIA-PACK CEA CALIBRATION VERIFICATION TEST SET by Tosoh Medics, Inc. — Product Code DHX

K924857 is an FDA 510(k) premarket notification submitted by Tosoh Medics, Inc. for the device "AIA-PACK CEA CALIBRATION VERIFICATION TEST SET". The FDA issued a decision of Substantially Equivalent on March 18, 1993. The device falls under product code DHX (System, Test, Carcinoembryonic Antigen), a Class II device regulated under 21 CFR 866.6010. Tosoh Medics, Inc. has at least 10 other 510(k) clearances on record.