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GTN — Antisera, Fluorescent, All Types, Staphylococcus Spp. Class I

FDA Device Classification

Classification Details

Product Code
GTN
Device Class
Class I
Regulation Number
866.3700
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K855236oxoid u.s.aDIAGNOSTIC REAGENT TST-RPLANovember 4, 1986
K855233oxoid u.s.aDIAGNOSTIC REAGENT SET-RPLANovember 4, 1986
K851949wellcome diagnosticsSTAPHAUREX ZL30May 22, 1985
K791453volu sol medical industriesAGGLUTINOTEST-STAPHYLOLISINSeptember 24, 1979