The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Lkb 2189 Ultroprocessor.
| Device ID | K843506 |
| 510k Number | K843506 |
| Device Name: | LKB 2189 ULTROPROCESSOR |
| Classification | Processor, Tissue, Automated |
| Applicant | LKB INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Contact | Ed Zior |
| Correspondent | Ed Zior LKB INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IEO |
| CFR Regulation Number | 864.3875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-06 |
| Decision Date | 1984-11-30 |