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GOK — Antisera, Hai (Including Hai Control), Rubella Class II

FDA Device Classification

Classification Details

Product Code
GOK
Device Class
Class II
Regulation Number
866.3510
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K832228bd becton dickinson vacutainer systems preanalyticRUBASCAN LATEX CARD TESTSeptember 29, 1983
K810835abbott laboratoriesRUBAZYME - MMay 5, 1981
K792635electro-nucleonics laboratoriesANTIBODY TO RUBELLA VIRUSMarch 19, 1980
K792133microbiological assocRUBELISA TEST KITJanuary 11, 1980
K790122organonRUBANONFebruary 15, 1979
K781638ortho diagnosticsRUBINDEX*DIRECT SYSTEMDecember 20, 1978
K781392microbiological assocCYTOMEGILISH TEST KITOctober 24, 1978
K780010northeast biomedical labsGOAT ANTI-RUBELLA ANTISERAJanuary 20, 1978
K780063organonRUBENOSTICONJanuary 20, 1978
K771956flow laboratoriesHUMAN O BUFFEROctober 28, 1977
K771957flow laboratoriesRUBELLA HEMAGGLUTINATION REAGENT KITOctober 28, 1977