510(k) K974816

ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 by Beckman Instruments, Inc. — Product Code LTJ

K974816 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229". The FDA issued a decision of Substantially Equivalent on February 20, 1998. The device falls under product code LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers), a Class II device regulated under 21 CFR 866.6010. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.