GJZ — Cyanomethemoglobin Reagent And Standard Solution Class II

FDA Device Classification

FDA product code GJZ covers "Cyanomethemoglobin Reagent And Standard Solution", a Class II medical device regulated under 21 CFR 864.7500. Submissions are reviewed by the Hematology panel. At least 2 recent 510(k) clearances have been granted under this product code.