The following data is part of a premarket notification filed by American Micro Scan with the FDA for Saf Fixative.
| Device ID | K831058 |
| 510k Number | K831058 |
| Device Name: | SAF FIXATIVE |
| Classification | Fixative, Acid Containing |
| Applicant | AMERICAN MICRO SCAN 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LDW |
| 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 |