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KSK — Solution, Stabilized Enzyme Class II

FDA Device Classification

Classification Details

Product Code
KSK
Device Class
Class II
Regulation Number
864.9400
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K813342gamma biologicalsGAMMA CHLOROQUINE DIPHOSPHATE SOLUTIONMarch 4, 1982
K813404biological corp. of americaFREEZE DRIED FICINFebruary 10, 1982
K810803biological corp. of americaFREEZE DRIED PAPAINJuly 21, 1981
K780962hyland therapeutic div., travenol laboratoriesAUTOMATED ENZYMEJuly 27, 1978
K760123bd becton dickinson vacutainer systems preanalyticAUTOZYMEJuly 20, 1976