KEA — Resins, Ion-Exchange Class I
FDA product code KEA covers "Resins, Ion-Exchange", a Class I medical device regulated under 21 CFR 862.2230. Submissions are reviewed by the Clinical Chemistry panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KEA
- Device Class
- Class I
- Regulation Number
- 862.2230
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K890997 | atlantic wholesale | ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) | March 28, 1989 |
| K844948 | syva | SYVA SOLID PHASE COLUMNS | August 29, 1985 |
| K842028 | lkb instruments | CM-TRISACRYL M DEAE-TRISACRYL M | June 7, 1984 |
| K833320 | biosan laboratories | AMBERLITE CG50 RESIN, 100-200 MESH | December 8, 1983 |
| K833319 | biosan laboratories | BIO-REX 70 RESIN 100-200 MESH PH6.2 | November 3, 1983 |
| K831027 | emd chemicals | EXTRELUT QE EXTRACTION COLUMNS | May 16, 1983 |
| K830918 | berwick medical products | I.E.C COLUMN | April 27, 1983 |
| K782066 | mcb manufacturing chemists | EXETRELUT | January 3, 1979 |
| K781728 | analytichem international | EXTUBE | December 20, 1978 |