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DGP — Ige, Fitc, Antigen, Antiserum, Control Class II

FDA Device Classification

Classification Details

Product Code
DGP
Device Class
Class II
Regulation Number
866.5510
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K931224biomerieux vitekVIDAS TOTAL IGE (IGE) ASSAYMay 20, 1993
K863327sclavoIMMPULSE IGE ASSAY REAGENTSDecember 3, 1986
K842749intl. diagnostic technologyFIAX TOTAL IGE TEST KITAugust 28, 1984
K842969allergeneticsALLERGENETICS ALLER-SPECIFIC IGE SERUMAugust 28, 1984