510(k) K111211

CELL-DYN 22 PLUS CONTROL by Streck — Product Code GLQ

K111211 is an FDA 510(k) premarket notification submitted by Streck for the device "CELL-DYN 22 PLUS CONTROL". The FDA issued a decision of Substantially Equivalent on December 22, 2011. The device falls under product code GLQ (Mixture, Control, White-Cell And Red-Cell Indices), a Class II device regulated under 21 CFR 864.8625. Streck has at least 10 other 510(k) clearances on record.