510(k) K981354

ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 by Beckman Instruments, Inc. — Product Code LOJ

K981354 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211". The FDA issued a decision of Substantially Equivalent on May 1, 1998. The device falls under product code LOJ (Kit, Test,Alpha-Fetoprotein For Testicular Cancer), a Class II device regulated under 21 CFR 866.6010. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.