CZX — Hemopexin, Antigen, Antiserum, Control Class II

FDA Device Classification

FDA product code CZX covers "Hemopexin, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5490. Submissions are reviewed by the Immunology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
CZX
Device Class
Class II
Regulation Number
866.5490
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K801432j.t. baker chemicalHEMOPEXIN NEPHELOMETRIC ASSAYJuly 8, 1980
K790713kent laboratoriesANTISERUM TO HUMAN HEMOPEXINSeptember 4, 1979
K780250kallestad laboratoriesHEMOPEXIN NEPHELOMETRIC ASSAYSFebruary 28, 1978