510(k) K971508

RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE by Bio-Whittaker, Inc., A Cambrex Co. — Product Code KIR

K971508 is an FDA 510(k) premarket notification submitted by Bio-Whittaker, Inc., A Cambrex Co. for the device "RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE". The FDA issued a decision of Substantially Equivalent on September 17, 1997. The device falls under product code KIR (Cells, Animal And Human, Cultured), a Class I device regulated under 21 CFR 864.2280. Bio-Whittaker, Inc., A Cambrex Co. has at least 2 other 510(k) clearances on record.