Resins, Ion-Exchange
Ion-exchange resins are laboratory materials used in clinical chemistry applications to separate, purify, or concentrate analytes from biological samples by selectively binding and releasing ions, supporting a variety of analytical procedures such as amino acid analysis or sample preparation for chromatography. They are classified as FDA Class 1 devices, the lowest risk category, subject only to general controls and not requiring premarket clearance. Product code KEA is regulated under 21 CFR 862.2230 in the Clinical Chemistry medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KEA
- Device Class
- FDA class 1
- Regulation Number
- 862.2230
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K890997 | ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) | Mar 28, 1989 | Substantially Equivalent | Atlantic Wholesale, Inc. |
| K844948 | SYVA SOLID PHASE COLUMNS | Aug 29, 1985 | Substantially Equivalent | Syva Co. |
| K842028 | CM-TRISACRYL M DEAE-TRISACRYL M | Jun 07, 1984 | Substantially Equivalent | Lkb Instruments, Inc. |
| K833320 | AMBERLITE CG50 RESIN, 100-200 MESH | Dec 08, 1983 | Substantially Equivalent | Biosan Laboratories, Inc. |
| K833319 | BIO-REX 70 RESIN 100-200 MESH PH6.2 | Nov 03, 1983 | Substantially Equivalent | Biosan Laboratories, Inc. |
| K831027 | EXTRELUT QE EXTRACTION COLUMNS | May 16, 1983 | Substantially Equivalent | Emd Chemicals, Inc. |
| K830918 | I.E.C COLUMN | Apr 27, 1983 | Substantially Equivalent | Berwick Medical Products, Inc. |
| K782066 | EXETRELUT | Jan 03, 1979 | Substantially Equivalent | Mcb Manufacturing Chemists, Inc. |
| K781728 | EXTUBE | Dec 20, 1978 | Substantially Equivalent | Analytichem International, Inc. |