510(k) K090123

NEONATAL BIOTINIDASE KIT, MODEL 3018 by Perkinelmer, Inc. — Product Code NAK

K090123 is an FDA 510(k) premarket notification submitted by Perkinelmer, Inc. for the device "NEONATAL BIOTINIDASE KIT, MODEL 3018". The FDA issued a decision of Substantially Equivalent on March 5, 2010. The device falls under product code NAK (System, Test, Biotinidase), a Class II device regulated under 21 CFR 862.1118. Perkinelmer, Inc. has at least 10 other 510(k) clearances on record.