The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Lkb-wallac 1230 Arcus Fluorometer.
| Device ID | K851984 |
| 510k Number | K851984 |
| Device Name: | LKB-WALLAC 1230 ARCUS FLUOROMETER |
| Classification | Fluorometer, For Clinical Use |
| 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 | KHO |
| CFR Regulation Number | 862.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-07 |
| Decision Date | 1985-05-24 |