I.E.C Column

FDA 510(k) K830918 · Berwick Medical Products, Inc.

Substantially Equivalent

510(k) numberK830918

Submission

Device name
I.E.C Column
Applicant
Berwick Medical Products, Inc.
Mchenry, IL, US
Received
March 22, 1983
Decision date
April 27, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KEA – Resins, Ion-Exchange
Device class
Class I (low risk)
Regulation
21 CFR 862.2230
Specialty
Clinical Chemistry

Other 510(k)s with product code KEA

510(k)DeviceApplicantDecision
K890997Zavos Disposable Filtration Column (ZDFC)KEA · Traditional Atlantic Wholesale, Inc.03/28/1989SE
K844948Syva Solid Phase ColumnsKEA · Traditional Syva Co.08/29/1985SE
K842028Cm-Trisacryl M Deae-Trisacryl MKEA · Traditional Lkb Instruments, Inc.06/07/1984SE
K833320Amberlite CG50 Resin, 100-200 MeshKEA · Traditional Biosan Laboratories, Inc.12/08/1983SE
K833319Bio-Rex 70 Resin 100-200 Mesh PH6.2KEA · Traditional Biosan Laboratories, Inc.11/03/1983SE
K831027Extrelut Qe Extraction ColumnsKEA · Traditional Emd Chemicals, Inc.05/16/1983SE
K782066ExetrelutKEA · Traditional Mcb Manufacturing Chemists, Inc.01/03/1979SE
K781728ExtubeKEA · Traditional Analytichem International, Inc.12/20/1978SE

More from Analytichem International, Inc.

510(k)DeviceDecision
K850800Dropstirs - Plastic Disposable PipetJQW · Traditional 04/02/1985SE
K842018Iso-Sep SystemCEX · Traditional 09/28/1984SE
K831434Iso-Sep SystemCDP · Traditional 06/30/1983SE
K831289Prefilled Iec ColumnsDJY · Traditional 06/16/1983SE

Questions and answers

When was I.E.C Column cleared by the FDA?

I.E.C Column (K830918) received a 510(k) decision of Substantially Equivalent on April 27, 1983, 36 days after the submission was received.

What is the product code of K830918?

The FDA product code is KEA – Resins, Ion-Exchange, a Class I (low risk) device regulated under 21 CFR 862.2230.