KEA
9 FDA 510(k) clearances · Product code
38 daysmedian time to decision
252 days90th percentile
9clearances measured
FDA profile
- Official device name
- Resins, Ion-Exchange
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2230
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) (K890997) | Atlantic Wholesale, Inc. | 1989-03-28 |
| SYVA SOLID PHASE COLUMNS (K844948) | Syva Co. | 1985-08-29 |
| CM-TRISACRYL M DEAE-TRISACRYL M (K842028) | Lkb Instruments, Inc. | 1984-06-07 |
| AMBERLITE CG50 RESIN, 100-200 MESH (K833320) | Biosan Laboratories, Inc. | 1983-12-08 |
| BIO-REX 70 RESIN 100-200 MESH PH6.2 (K833319) | Biosan Laboratories, Inc. | 1983-11-03 |
| EXTRELUT QE EXTRACTION COLUMNS (K831027) | Emd Chemicals, Inc. | 1983-05-16 |
| I.E.C COLUMN (K830918) | Berwick Medical Products, Inc. | 1983-04-27 |
| EXETRELUT (K782066) | Mcb Manufacturing Chemists, Inc. | 1979-01-03 |
| EXTUBE (K781728) | Analytichem International, Inc. | 1978-12-20 |
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Every clearance here is in the API, with alerts when new ones post.