510(k) K874151

RF DIPSTICK TEST KIT by Lipogen, Inc. — Product Code DHR

K874151 is an FDA 510(k) premarket notification submitted by Lipogen, Inc. for the device "RF DIPSTICK TEST KIT". The FDA issued a decision of Substantially Equivalent on December 29, 1987. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Lipogen, Inc. has at least 10 other 510(k) clearances on record.