The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Trisacryl Gf 05 & Trisacryl Gf 2000.
| Device ID | K840985 |
| 510k Number | K840985 |
| Device Name: | TRISACRYL GF 05 & TRISACRYL GF 2000 |
| Classification | Ion-exchange Chromatography |
| Applicant | LKB INSTRUMENTS, 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 | 1984-03-07 |
| Decision Date | 1984-04-19 |