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DAS — Igg (Fc Fragment Specific), Antigen, Antiserum, Control Class I

FDA Device Classification

Classification Details

Product Code
DAS
Device Class
Class I
Regulation Number
866.5530
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K982023inova diagnosticsPELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KITSeptember 4, 1998
K944876research diagnosticsHUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KITDecember 15, 1994
K943205research diagnosticsHUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)September 7, 1994
K943098research diagnosticsHUMAN IGG SUBCLASSES ELISA COMBI KITSeptember 7, 1994
K895600binding siteHUMAN (IGG) SUBCLASS (EIA) KITNovember 8, 1989
K790708kent laboratoriesANTISERUM TO HUMAN IG G FC FRAGMENTSAugust 22, 1979
K790715kent laboratoriesANTISERUM TO HUMAN FCAugust 16, 1979
K761156supelcoAMINOGLYCOSIDE CONTROLSDecember 9, 1976