The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Pleascent Or Forma-scent.
| Device ID | K802506 |
| 510k Number | K802506 |
| Device Name: | PLEASCENT OR FORMA-SCENT |
| Classification | Formaldehyde (formalin, Formol) |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IGG |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-15 |
| Decision Date | 1980-11-12 |