The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Extrelut Qe Extraction Columns.
| Device ID | K831027 |
| 510k Number | K831027 |
| Device Name: | EXTRELUT QE EXTRACTION COLUMNS |
| Classification | Resins, Ion-exchange |
| Applicant | EMD CHEMICALS INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KEA |
| CFR Regulation Number | 862.2230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-30 |
| Decision Date | 1983-05-16 |