Exetrelut

FDA 510(k) K782066 · Mcb Manufacturing Chemists, Inc.

Substantially Equivalent

510(k) numberK782066

Submission

Device name
Exetrelut
Applicant
Mcb Manufacturing Chemists, Inc.
Mchenry, IL, US
Received
December 13, 1978
Decision date
January 3, 1979
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
K830918I.E.C ColumnKEA · Traditional Berwick Medical Products, Inc.04/27/1983SE
K781728ExtubeKEA · Traditional Analytichem International, Inc.12/20/1978SE

More from Analytichem International, Inc.

510(k)DeviceDecision
K801212Wrights Rapid StainIAF · Traditional 05/30/1980SE
K800847EntellanKEP · Traditional 05/08/1980SE
K792026Wrights Rapid StainIAF · Traditional 11/13/1979SE
K791929Wrights Rapid StainIAF · Traditional 10/11/1979SE

Questions and answers

When was Exetrelut cleared by the FDA?

Exetrelut (K782066) received a 510(k) decision of Substantially Equivalent on January 3, 1979, 21 days after the submission was received.

What is the product code of K782066?

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