KEA · Resins, Ion-Exchange
Clinical Chemistry · 21 CFR 862.2230 · Class 1
Overview
| Product Code | KEA |
|---|---|
| Device Name | Resins, Ion-Exchange |
| Regulation | 21 CFR 862.2230 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A chromatographic separation material for clinical use is a device accessory (e.g., ion exchange absorbents, ion exchagne resins, and ion papers) intended for use in ion exchange chromatography, a procedure in which a compound is separated from a solution.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K890997 | ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) | Atlantic Wholesale, Inc. | Mar 28, 1989 | SESE |
| K844948 | SYVA SOLID PHASE COLUMNS | Syva Co. | Aug 29, 1985 | SESE |
| K842028 | CM-TRISACRYL M DEAE-TRISACRYL M | Lkb Instruments, Inc. | Jun 7, 1984 | SESE |
| K833320 | AMBERLITE CG50 RESIN, 100-200 MESH | Biosan Laboratories, Inc. | Dec 8, 1983 | SESE |
| K833319 | BIO-REX 70 RESIN 100-200 MESH PH6.2 | Biosan Laboratories, Inc. | Nov 3, 1983 | SESE |
| K831027 | EXTRELUT QE EXTRACTION COLUMNS | Emd Chemicals, Inc. | May 16, 1983 | SESE |
| K830918 | I.E.C COLUMN | Berwick Medical Products, Inc. | Apr 27, 1983 | SESE |
| K782066 | EXETRELUT | Mcb Manufacturing Chemists, Inc. | Jan 3, 1979 | SESE |
| K781728 | EXTUBE | Analytichem International, Inc. | Dec 20, 1978 | SESE |
Top Applicants
- Biosan Laboratories, Inc. — 2 clearances
- Analytichem International, Inc. — 1 clearance
- Atlantic Wholesale, Inc. — 1 clearance
- Berwick Medical Products, Inc. — 1 clearance
- Emd Chemicals, Inc. — 1 clearance
