The following data is part of a premarket notification filed by Analytichem International, Inc. with the FDA for Bond Elut Columns.
| Device ID | K800061 |
| 510k Number | K800061 |
| Device Name: | BOND ELUT COLUMNS |
| Classification | Ion-exchange Chromatography |
| Applicant | ANALYTICHEM INTERNATIONAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DJY |
| CFR Regulation Number | 862.2230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-09 |
| Decision Date | 1980-03-12 |