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KSX — Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use Class II

FDA Device Classification

Classification Details

Product Code
KSX
Device Class
Class II
Regulation Number
864.9160
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K802533gamma biologicalsGAMMA LEWIS BLOOD GROUP SUBSTANCENovember 12, 1980
K802534gamma biologicalsGAMMA PI BLOOD GROUP SUBSTANCENovember 12, 1980
K800916travenol laboratoriesP1 BLOOD GROUP SUBSTANCEMay 8, 1980
K781862north american biologicalsBLOOD GROUP SUBSTANCE ADecember 20, 1978
K781895north american biologicalsBLOOD GROUP SUBSTANCE BDecember 20, 1978
K781896north american biologicalsBLOOD GROUP SUBSTANCE A,BDecember 20, 1978
K771487ortho diagnosticsLEWIS BLOOD GROUP SUBSTANCENovember 8, 1977
K771488ortho diagnosticsP1 BLOOD GROUP SUBSTANCENovember 8, 1977