The following data is part of a premarket notification filed by Surgipath with the FDA for Ea 65.
| Device ID | K812086 |
| 510k Number | K812086 |
| Device Name: | EA 65 |
| Classification | Stain, Papanicolau |
| Applicant | SURGIPATH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HZJ |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-22 |
| Decision Date | 1981-08-13 |