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GNB — Antisera, All Types, Shigella Spp. Class II

FDA Device Classification

Classification Details

Product Code
GNB
Device Class
Class II
Regulation Number
866.3660
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K961537sa scientificSAS SHIGELLA SONNEI FORM II ANTISERUMMay 31, 1996
K961532sa scientificSAS SHIGELLA FLEXNERI TYPE 5 ANTISERUMMay 20, 1996
K961538sa scientificSAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUMMay 20, 1996
K961546sa scientificSAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUMMay 20, 1996
K961558sa scientificSAS SHIGELLA FLEXNERI TYPE 3 ANTISERUMMay 20, 1996
K961540sa scientificSAS SHIGELLA SONNEI GROUP D ANTISERUMMay 20, 1996
K961548sa scientificSAS SHIGELLA BOYDII TYPE 15 ANTISERUMMay 20, 1996
K961543sa scientificSAS SHIGELLA BOYDII TYPE 9 ANTISERUMMay 20, 1996
K961535sa scientificSAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUMMay 20, 1996
K961549sa scientificSAS SHIGELLA FLEXNERI TYPE 2 ANTISERUMMay 20, 1996
K961531sa scientificSAS SHIGELLA BOYDII TYPE 13 ANTISERUMMay 20, 1996
K961551sa scientificSAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUMMay 20, 1996
K961559sa scientificSAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUMMay 20, 1996
K961533sa scientificSAS SHIGELLA FLEXNERI TYPE 6 ANTISERUMMay 20, 1996
K961529sa scientificSAS SHIGELLA BOYDII TYPE 12 ANTISERUMMay 20, 1996
K961541sa scientificSAS SHIGELLA BOYDII TYPE 8 ANTISERUMMay 20, 1996
K961547sa scientificSAS SHIGELLA BOYDII TYPE 14 ANTISERUMMay 20, 1996
K961556sa scientificSAS SHIGELLA FLEXNERI TYPE 1 ANTISERUMMay 20, 1996
K961539sa scientificSAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUMMay 20, 1996
K961542sa scientificSAS SHIGELLA FLEXNERI TYPE 4 ANTISERUMMay 20, 1996