510(k) K882623

PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM by Technicon Instruments Corp. — Product Code JZH

K882623 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM". The FDA issued a decision of Substantially Equivalent on July 8, 1988. The device falls under product code JZH (Factor B, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5320. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.