The following data is part of a premarket notification filed by Dutchland Laboratories, Inc. with the FDA for Trypan Blue (0.5% In Normal Saline).
| Device ID | K810782 |
| 510k Number | K810782 |
| Device Name: | TRYPAN BLUE (0.5% IN NORMAL SALINE) |
| Classification | Trypan Blue |
| Applicant | DUTCHLAND LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LGY |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-23 |
| Decision Date | 1981-05-13 |