KEA — Resins, Ion-Exchange Class I

FDA Device Classification

Classification Details

Product Code
KEA
Device Class
Class I
Regulation Number
862.2230
Submission Type
Review Panel
TX
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K890997atlantic wholesaleZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)March 28, 1989
K844948syvaSYVA SOLID PHASE COLUMNSAugust 29, 1985
K842028lkb instrumentsCM-TRISACRYL M DEAE-TRISACRYL MJune 7, 1984
K833320biosan laboratoriesAMBERLITE CG50 RESIN, 100-200 MESHDecember 8, 1983
K833319biosan laboratoriesBIO-REX 70 RESIN 100-200 MESH PH6.2November 3, 1983
K831027emd chemicalsEXTRELUT QE EXTRACTION COLUMNSMay 16, 1983
K830918berwick medical productsI.E.C COLUMNApril 27, 1983
K782066mcb manufacturing chemistsEXETRELUTJanuary 3, 1979
K781728analytichem internationalEXTUBEDecember 20, 1978