The following data is part of a premarket notification filed by American Micro Scan with the FDA for Pva Fixative/formalin.
| Device ID | K831061 |
| 510k Number | K831061 |
| Device Name: | PVA FIXATIVE/FORMALIN |
| Classification | Fixative, Alcohol Containing |
| Applicant | AMERICAN MICRO SCAN 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LDZ |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-01 |
| Decision Date | 1983-06-08 |