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DBY — Fab, Rhodamine, Antigen, Antiserum, Control Class I

FDA Device Classification

Classification Details

Product Code
DBY
Device Class
Class I
Regulation Number
866.5520
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K022067boston scientificCONVOY ADVANCED DELIVERY SHEATHSeptember 11, 2002
K013919baylis medical coTORFLEX TRANSSEPTAL GUIDING SHEATHFebruary 22, 2002
K013304becton dickinson infusion therapy systemsBD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCERJanuary 2, 2002
K013282w.l. gore and associatesGORE INTRODUCER SHEATHDecember 14, 2001
K013866boston scientificCONVOY ADVANCED DELIVERY SHEATH KITDecember 14, 2001
K771144kent laboratoriesRHODAMINE-CONJUGATED ANTISERUMJuly 14, 1977