The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Reactifs, Ibf Ultrogels Aca & Ultrogels A.
| Device ID | K844164 |
| 510k Number | K844164 |
| Device Name: | REACTIFS, IBF ULTROGELS ACA & ULTROGELS A |
| Classification | Columns, Glc |
| Applicant | LKB INSTRUMENTS, INC. 9319 GAITHER RD. Gaithersburg, MD 20877 |
| Contact | Ed Zior |
| Correspondent | Ed Zior LKB INSTRUMENTS, INC. 9319 GAITHER RD. Gaithersburg, MD 20877 |
| Product Code | DII |
| CFR Regulation Number | 862.2250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-25 |
| Decision Date | 1984-12-10 |