510(k) K962158

PICO MODELS 30, 50, 70 by Radiometer America, Inc. — Product Code JKA

K962158 is an FDA 510(k) premarket notification submitted by Radiometer America, Inc. for the device "PICO MODELS 30, 50, 70". The FDA issued a decision of Substantially Equivalent on October 29, 1996. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Radiometer America, Inc. has at least 10 other 510(k) clearances on record.