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FDA Product Code

FDA Product Code KEA — Clearance Directory

Device Class
Class I
Assigned Panel
Clinical Chemistry
21 CFR Citation
862.2230

510(k) Clearances — 9 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K890997 ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) Atlantic Wholesale, Inc. 1989-03-28 Traditional PDF ↗
K844948 SYVA SOLID PHASE COLUMNS Syva Co. 1985-08-29 Traditional PDF ↗
K842028 CM-TRISACRYL M DEAE-TRISACRYL M Lkb Instruments, Inc. 1984-06-07 Traditional PDF ↗
K833320 AMBERLITE CG50 RESIN, 100-200 MESH Biosan Laboratories, Inc. 1983-12-08 Traditional PDF ↗
K833319 BIO-REX 70 RESIN 100-200 MESH PH6.2 Biosan Laboratories, Inc. 1983-11-03 Traditional PDF ↗
K831027 EXTRELUT QE EXTRACTION COLUMNS Emd Chemicals, Inc. 1983-05-16 Traditional PDF ↗
K830918 I.E.C COLUMN Berwick Medical Products, Inc. 1983-04-27 Traditional PDF ↗
K782066 EXETRELUT Mcb Manufacturing Chemists, Inc. 1979-01-03 Traditional PDF ↗
K781728 EXTUBE Analytichem International, Inc. 1978-12-20 Traditional PDF ↗

Product code KEA · Class I · Clinical Chemistry. Data: openFDA.