FDA 510(k) Applications for Medical Device Product Code "DEX"
(Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K791341 BECKMAN INSTRUMENTS, INC. HUMAN ALPHA, ACID GLYCOPROTEIN 08/16/1979
K781023 ICL SCIENTIFIC ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU 08/14/1978
K792314 ICL SCIENTIFIC RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN 12/06/1979
K801909 J.T. BAKER CHEMICAL CO. LSA 290 ASSAY REAGENTS/NEPHELOMETRIC 09/26/1980
K823765 KENT LABORATORIES, INC. ANTI SERA TO HUMAN OROSCOMUCOID 12/30/1982
K760143 OXFORD LABORATORIES, INC. SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN 07/20/1976


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