510(k) K965033

IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT by Beckman Instruments, Inc. — Product Code MGA

K965033 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT". The FDA issued a decision of Substantially Equivalent on April 21, 1997. The device falls under product code MGA (Alpha-1 Microglobulin, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5400. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.