510(k) K023894

ST AIA-PACK AFP ENZYME IMMUNOASSAY by Tosoh Medics, Inc. — Product Code LOJ

K023894 is an FDA 510(k) premarket notification submitted by Tosoh Medics, Inc. for the device "ST AIA-PACK AFP ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on December 17, 2002. The device falls under product code LOJ (Kit, Test,Alpha-Fetoprotein For Testicular Cancer), a Class II device regulated under 21 CFR 866.6010. Tosoh Medics, Inc. has at least 10 other 510(k) clearances on record.