Prefilled Iec Columns

FDA 510(k) K831289 · Berwick Medical Products, Inc.

Substantially Equivalent

510(k) numberK831289

Submission

Device name
Prefilled Iec Columns
Applicant
Berwick Medical Products, Inc.
Mchenry, IL, US
Received
April 20, 1983
Decision date
June 16, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code DJY

510(k)DeviceApplicantDecision
K890113The Cdi(R) System 400DJY · Traditional Cardiovascular Devices, Inc.05/23/1989SE
K883615Liquid Chromatography Columns 5-7070/71/72/73DJY · Traditional Supelco, Inc.12/16/1988SE
K881361Solid Phase Extraction TubesDJY · Traditional Supelco, Inc.08/08/1988SE
K850963Dupont Prep Type Si Extraciton CartridgeDJY · Traditional E.I. Dupont DE Nemours & Co., Inc.03/25/1985SE
K840985Trisacryl GF 05 & Trisacryl GF 2000DJY · Traditional Lkb Instruments, Inc.04/19/1984SE
K832198HC40/HC75 Prepacked ColumsDJY · Traditional Hamilton Co.08/12/1983SE
K830693Dupont Prep Type AS Extraction CartrideDJY · Traditional E.I. Dupont DE Nemours & Co., Inc.04/05/1983SE
K830692Dupont Prep Od Extraction CartrideDJY · Traditional E.I. Dupont DE Nemours & Co., Inc.04/05/1983SE
K823697Prep Type a Extraction CartridgeDJY · Traditional E.I. Dupont DE Nemours & Co., Inc.01/05/1983SE
K800061Bond Elut ColumnsDJY · Traditional Analytichem International, Inc.03/12/1980SE

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
K830918I.E.C ColumnKEA · Traditional 04/27/1983SE

Questions and answers

When was Prefilled Iec Columns cleared by the FDA?

Prefilled Iec Columns (K831289) received a 510(k) decision of Substantially Equivalent on June 16, 1983, 57 days after the submission was received.

What is the product code of K831289?

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