The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for 4050/4051 Ultraspec.
| Device ID | K820273 |
| 510k Number | K820273 |
| Device Name: | 4050/4051 ULTRASPEC |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | LKB INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-02 |
| Decision Date | 1982-02-18 |