510(k) K771098

BLOOD GROUPING SYS., BG-9 by Technicon Instruments Corp. — Product Code KSZ

K771098 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "BLOOD GROUPING SYS., BG-9". The FDA issued a decision of Substantially Equivalent on August 4, 1977. The device falls under product code KSZ (System, Test, Automated Blood Grouping And Antibody), a Class II device regulated under 21 CFR 864.9175. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.