510(k) K930389

ONE DRAM SHELL VIAL, CATALOG #02-291 by Proteins Intl., Inc. — Product Code KIR

K930389 is an FDA 510(k) premarket notification submitted by Proteins Intl., Inc. for the device "ONE DRAM SHELL VIAL, CATALOG #02-291". The FDA issued a decision of Substantially Equivalent on March 23, 1993. The device falls under product code KIR (Cells, Animal And Human, Cultured), a Class I device regulated under 21 CFR 864.2280. Proteins Intl., Inc. has at least 10 other 510(k) clearances on record.