Amberlite CG50 Resin, 100-200 Mesh
FDA 510(k) K833320 · Biosan Laboratories, Inc.
510(k) numberK833320
Submission
- Device name
- Amberlite CG50 Resin, 100-200 Mesh
- Applicant
- Biosan Laboratories, Inc.
Mchenry, IL, US - Received
- September 26, 1983
- Decision date
- December 8, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K890997 | Zavos Disposable Filtration Column (ZDFC)KEA · Traditional | Atlantic Wholesale, Inc. | 03/28/1989SE |
| K844948 | Syva Solid Phase ColumnsKEA · Traditional | Syva Co. | 08/29/1985SE |
| K842028 | Cm-Trisacryl M Deae-Trisacryl MKEA · Traditional | Lkb Instruments, Inc. | 06/07/1984SE |
| K833319 | Bio-Rex 70 Resin 100-200 Mesh PH6.2KEA · Traditional | Biosan Laboratories, Inc. | 11/03/1983SE |
| K831027 | Extrelut Qe Extraction ColumnsKEA · Traditional | Emd Chemicals, Inc. | 05/16/1983SE |
| K830918 | I.E.C ColumnKEA · Traditional | Berwick Medical Products, Inc. | 04/27/1983SE |
| K782066 | ExetrelutKEA · Traditional | Mcb Manufacturing Chemists, Inc. | 01/03/1979SE |
| K781728 | ExtubeKEA · Traditional | Analytichem International, Inc. | 12/20/1978SE |
More from Analytichem International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K860642 | Photron Visual Field AnalyzerHOM · Traditional | 04/15/1986SE |
| K853812 | Photron Neurovisual Stimulator(Modification)HLX · Traditional | 11/01/1985SE |
| K832763 | Tobramycin ReagentKLB · Traditional | 03/23/1984SE |
| K833193 | Radioimmunoassay, Thyroid Stimu. HormoneJLW · Traditional | 02/04/1984SE |
| K834023 | Bio-Science Laboratories T4 ReagentCDX · Traditional | 01/24/1984SE |
| K833318 | Normal Goat SerumDHX · Traditional | 01/03/1984SE |
| K833192 | Normal Urine ControlJJY · Traditional | 12/08/1983SE |
| K833191 | Abnormal Urine ControlJJY · Traditional | 12/08/1983SE |
| K833319 | Bio-Rex 70 Resin 100-200 Mesh PH6.2KEA · Traditional | 11/03/1983SE |
Questions and answers
When was Amberlite CG50 Resin, 100-200 Mesh cleared by the FDA?
Amberlite CG50 Resin, 100-200 Mesh (K833320) received a 510(k) decision of Substantially Equivalent on December 8, 1983, 73 days after the submission was received.
What is the product code of K833320?
The FDA product code is KEA – Resins, Ion-Exchange, a Class I (low risk) device regulated under 21 CFR 862.2230.