The following data is part of a premarket notification filed by Cytocorp, Inc. with the FDA for Diacyte Fixative Solution.
| Device ID | K880549 |
| 510k Number | K880549 |
| Device Name: | DIACYTE FIXATIVE SOLUTION |
| Classification | Fixative, Formalin-containing |
| Applicant | CYTOCORP, INC. 601 ROCKWELL AVE. SUITE 314 Cleveland, OH 44114 |
| Contact | Kay Maksem |
| Correspondent | Kay Maksem CYTOCORP, INC. 601 ROCKWELL AVE. SUITE 314 Cleveland, OH 44114 |
| Product Code | LDY |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-09 |
| Decision Date | 1988-04-01 |