510(k) K882621

COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM by Technicon Instruments Corp. — Product Code DBI

K882621 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM". The FDA issued a decision of Substantially Equivalent on July 8, 1988. The device falls under product code DBI (Complement C4, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.