The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Papanicolaou Stain Sys Ht40.
| Device ID | K840054 |
| 510k Number | K840054 |
| Device Name: | PAPANICOLAOU STAIN SYS HT40 |
| Classification | Stain, Papanicolau |
| Applicant | SIGMA CHEMICAL CO. 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 | 1984-01-06 |
| Decision Date | 1984-02-17 |