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DEX — Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control Class I

FDA Device Classification

Classification Details

Product Code
DEX
Device Class
Class I
Regulation Number
866.5420
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K823765kent laboratoriesANTI SERA TO HUMAN OROSCOMUCOIDDecember 30, 1982
K801909j.t. baker chemicalLSA 290 ASSAY REAGENTS/NEPHELOMETRICSeptember 26, 1980
K791341beckman instrumentsHUMAN ALPHA, ACID GLYCOPROTEINAugust 16, 1979
K781023icl scientificALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HUAugust 14, 1978
K760143oxford laboratoriesSERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMANJuly 20, 1976