KEA · Class I · 21 CFR 862.2230

FDA Product Code KEA: Resins, Ion-exchange

Leading manufacturers include Biosan Laboratories, Inc., Lkb Instruments, Inc. and Syva Co..

9
Total
9
Cleared
66d
Avg days
1978
Since

FDA 510(k) Cleared Resins, Ion-exchange Devices (Product Code KEA)

9 devices
1–9 of 9
Cleared Mar 28, 1989
ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)
K890997
Atlantic Wholesale, Inc.
Chemistry · 29d
Cleared Aug 29, 1985
SYVA SOLID PHASE COLUMNS
K844948
Syva Co.
Chemistry · 252d
Cleared Jun 07, 1984
CM-TRISACRYL M DEAE-TRISACRYL M
K842028
Lkb Instruments, Inc.
Chemistry · 20d
Cleared Dec 08, 1983
AMBERLITE CG50 RESIN, 100-200 MESH
K833320
Biosan Laboratories, Inc.
Pathology · 73d
Cleared Nov 03, 1983
BIO-REX 70 RESIN 100-200 MESH PH6.2
K833319
Biosan Laboratories, Inc.
Toxicology · 38d
Cleared May 16, 1983
EXTRELUT QE EXTRACTION COLUMNS
K831027
Emd Chemicals, Inc.
Toxicology · 47d
Cleared Apr 27, 1983
I.E.C COLUMN
K830918
Berwick Medical Products, Inc.
Chemistry · 36d
Cleared Jan 03, 1979
EXETRELUT
K782066
Mcb Manufacturing Chemists, Inc.
Toxicology · 21d
Cleared Dec 20, 1978
EXTUBE
K781728
Analytichem International, Inc.
Toxicology · 75d

About Product Code KEA - Regulatory Context