The following data is part of a premarket notification filed by Luneau Laboratories with the FDA for Color Vision Testers.
| Device ID | K844365 |
| 510k Number | K844365 |
| Device Name: | COLOR VISION TESTERS |
| Classification | Tester, Color Vision |
| Applicant | LUNEAU LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HIT |
| CFR Regulation Number | 886.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-13 |
| Decision Date | 1985-01-02 |