KJI — Radioimmunoassay, Kanamycin Class II

FDA Device Classification

Classification Details

Product Code
KJI
Device Class
Class II
Regulation Number
862.3520
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K832769miles laboratoriesAMES TDA KANAMYCIN TEST-CONTROL SERUMSeptember 29, 1983
K823370syvaADVANCE TM EMIT(R) & TM AMIKACIN ASSAYDecember 3, 1982
K823062american diagnosticKENAMYCIN FLUORESCENT IMMUNOASSAY FIANovember 10, 1982
K822808abbott laboratoriesTDX KENAMYCINOctober 8, 1982
K782125diagnostic productsRIA KIT, KANAMYCINJanuary 10, 1979
K772038monitor scienceKANAMYCIN RIAJanuary 12, 1978