The following data is part of a premarket notification filed by Accra Laboratories, Inc. with the FDA for Stat Stain Set.
| Device ID | K810495 |
| 510k Number | K810495 |
| Device Name: | STAT STAIN SET |
| Classification | Wright's Stain |
| Applicant | ACCRA LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IAF |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-24 |
| Decision Date | 1981-03-17 |