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DEI — Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control Class II

FDA Device Classification

Classification Details

Product Code
DEI
Device Class
Class II
Regulation Number
866.5130
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K840867intl. diagnostic technologyALPHA-1-ANTITRYPSIN, FITC, ANTIGENMay 11, 1984
K772250kallestad laboratoriesALPHA-1-ANTITRYPSIN NEPHEL. ASSAYDecember 22, 1977