The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Cm-trisacryl M Deae-trisacryl M.
| Device ID | K842028 |
| 510k Number | K842028 |
| Device Name: | CM-TRISACRYL M DEAE-TRISACRYL M |
| Classification | Resins, Ion-exchange |
| Applicant | LKB INSTRUMENTS, 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 | 1984-05-18 |
| Decision Date | 1984-06-07 |